The Legal System

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For chemicals classification to work reliably and effectively, it is important for classifiers to have a clear set of rules to follow.

By following clear, shared rules when classifying, suppliers are able to give reliable, consistent, and objective advice to their customers. It also helps customers learn what different warning symbols and phrases mean, which is essential for hazard communication to be effective.

Laws on chemical classification and labelling establish the duty to classify chemicals and set out the rules that should be followed. Their aim is to improve:

  • knowledge of chemical hazards, ands
  • how information about these hazards is passed to users so that chemicals can be used and disposed of safely

Over time, these laws have been developed and refined. The current classification laws are sophisticated and incorporate a detailed technical system of classification criteria.

If you supply chemicals, it is important that you understand these laws and what you need to do to meet the necessary requirements.

Background: Globally Harmonised System (GHS)

All over the world there are different laws on how to identify the hazardous properties of chemicals (called ‘classification’) and how information about these hazards is then passed to users (through labels and safety data sheets for workers).

This can be confusing because the same chemical can have different hazard descriptions in different countries. For example, a chemical could be labelled as ‘toxic’ in one country but not in another. This also acts as a barrier to international trade.

The Earth Summit held in Rio de Janeiro in 1992 and the Word Summit held in Johannesburg in 2002 recognised this as an important global issue.

Given the expanding international market in chemical substances and mixtures, to help protect people and the environment, and to facilitate trade, the United Nations has therefore developed a ‘Globally Harmonised System’ (GHS) on classification and labelling.

The GHS is a single worldwide system for classifying and communicating the hazardous properties of industrial and consumer chemicals. GHS sits alongside the UN ‘Transport of Dangerous Goods’ system.

The UN brought together experts from different countries to create the GHS with the aim to have, worldwide, the same:

  • criteria for classifying chemicals according to their health, environmental and physical hazards; and
  • hazard communication requirements for labelling and safety data sheets.

The UN GHS is not a formal treaty, but instead is a non-legally binding international agreement. Therefore countries (or trading blocks) must create local or national legislation to implement the GHS.

The CLP Regulation adopts the GHS throughout the member states of the European Union.

The UN GHS aims to ensure that information on the hazardous properties of chemicals is available throughout the world in order to enhance the protection of human health and the environment during the handling, transport and use of chemicals. GHS also provides the basis for harmonising regulations on chemicals at national, regional and worldwide level. This is important for facilitating trade. At a more basic level, GHS also aims to provide a structure for countries that do not yet have a classification and labelling system.

The UN anticipates that once fully implemented, the GHS will:

  • enhance the protection of human health and the environment by providing a system for hazard communication that is comprehensible throughout the world;
  • provide a recognised framework for those countries without an existing system;
  • reduce the need for testing and evaluation of chemicals (agreeing/harmonising classification will help to reduce the need for animal testing); and
  • facilitate trade in chemicals whose hazards have been properly assessed and identified on an international basis.
  • The UN work programmes continue to develop and refine the UN GHS in biennial work programmes.

The GHS is sometimes referred to as the ‘Purple Book’ reflecting the purple binding of the published version of GHS. This is in keeping with the transport system which is often referred to as the ‘Orange Book’!

In the long run, GHS and the CLP Regulationshould make classification of mixtures easier, cheaper, more accurate, and allow for more flexibility on the part of the classifier.

The CLP Regulation

European Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures came into force on 20 January 2009 in all EU Member States, including the UK. It is known by its abbreviated form, ‘the CLP Regulation’ or just plain ‘CLP’.

The CLP Regulation adopts the United Nations’ Globally Harmonised System on the classification and labelling of chemicals (GHS) across all European Union countries, including the UK.

As GHS is a voluntary agreement rather than a law, it has to be adopted through a suitable national or regional legal mechanism to ensure it becomes legally binding. That’s what the CLP Regulation does.

As GHS was heavily influenced by the old EU system, the CLP Regulation is very similar in many ways. The duties on suppliers are broadly the same: classification, labelling and packaging.

The existing legislation on classification, labelling and packaging has been agreed at European Union level and, from 2015, will be directly applied on all EU member states, including the UK.

The rules they have to follow when they are classifying will change though, and a new set of hazard pictograms (quite similar to the old ones) are used:

GHS hazard pictograms

Hazard pictograms alert us to the presence of a hazardous chemical.  The pictograms help us to know that the chemicals we are using might cause harm to people or the environment.  The CLP hazard pictograms are very similar to those used in the old labelling system and appear in the shape of a diamond with a distinctive red border and white background.  One or more pictograms might appear on the labelling of a single chemical.

Please see the European Chemicals Agency (ECHA) website for CLP hazard pictograms:

Making changes to the CLP Regulation - ATPs

Like its predecessor Directives, the CLP Regulation is routinely updated to take account of scientific knowledge about chemicals and technical development. These amendments are known as adaptations to technical progress or ATPs.

In general there are two series of ATPs which run side-by-side:

  • proposed new harmonised substance classifications – these are independently assessed and, if agreed, will amend the list of entries in Annex VI to CLP. Expected to be every 12 months or so; and
  • amendments made to the classification criteria and technical annexes to the GHS:
    - These amendments reflect the biennial rhythm of the UN GHS, and need to be incorporated into CLP so would be expected every 2 years.
    - These amendments may also align GHS more closely to the transport regulations.

The ATPs are voted on by Member States and, if agreed, are published as European Commission Regulations.

How CLP affects other chemical law

The classification of a substance or mixture does not, in itself, restrict, ban or otherwise limit the use or market of that substance or mixture. However as chemical classification is a fundamental part of the safe management, handling and use of chemicals. It is often used as a starting point for other specific controls or protective measures. In many case these measures are set out in other legislation which refers to classification and labelling laws.

Affected chemical laws

Other chemical legislation which refers to the CLP Regulation includes:

  • REACH Regulation – restrictions can be affected by classification.  For example, substances classified as either a Category 1A or 1B carcinogen, mutagen or toxic for reproduction, cannot be supplied to the general public.
  • Control of Substances Hazardous to Health (COSHH) – the more severe the classification, the more likely the substance is to attract additional control measures under COSHH.
  • Control of Major Accident Hazards (COMAH) – certain classifications will result in COMAH controls applying to sites handling or storing them if tonnage thresholds are met.
  • Biocidal Products Regulation (BPR) – certain classifications are used in the authorisation/approval process under biocides legislation.
  • Plant Protection Products Regulation (PPPR) – certain classifications are used as exclusion criteria for approved use under PPPR.
  • Management of Health and Safety at Work (MHSW) – the classification of chemicals may need to be taken into account when managing pregnant workers or to ensure the protection of young people at work.
  • Cosmetics Regulation – substances with certain classifications are prohibited for being used in cosmetic products.

Chemicals not covered by CLP

Most industrial chemicals are covered by the CLP Regulation. Some chemicals that have a more specialised job are covered by more specific legislation.

The CLP Regulation does not apply to the following chemicals:

  • radioactive substances and mixtures
  • substances and mixtures subject to customs supervision
  • non-isolated intermediaries
  • substances and mixtures for scientific research and development which are not placed on the market and are only used in controlled conditions
  • waste

The CLP Regulation does not apply to the following chemicals which are in the finished state intended for the final user:

  • medicines
  • medical devices
  • veterinary medicines
  • cosmetics
  • food
  • feeding stuffs (i.e. food additive; food flavouring; feeding stuffs used in animal nutrition)

Except where Article 33 applies, the CLP Regulation does not apply to the transport of dangerous goods by air, sea, road, rail or inland waterways. More information on the interface between CLP (supply) and transport labelling can be found in ECHA's guidance:

Legislation

Enforcement of the CLP Regulation

Although the CLP Regulation is directly acting on all EU Member States, Article 43 requires Member States to put in place the necessary arrangements to enforce the Regulation.

The CLP Regulation is enforced by the HSE and local authorities (i.e. trading standards officers). The General Pharmaceutical Council also has very limited enforcement powers, restricted to certain types of premises (pharmacies).

In cases that involve environmental hazards, the Environment Agency, provide technical and scientific support.

Regulation 18 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 sets out the relevant enforcement powers.

Any enforcement action taken by HSE will be undertaken in accordance with HSENI’s Enforcement Policy.

CHIP Regulations

The CHIP Regulations were revoked from 1 June 2015 and no longer have legal effect. Chemical suppliers should comply with the CLP Regulation.

There are certain limited circumstances where CHIP labelling and packaging of mixtures (formerly preparations) can remain on the market after 1 June 2015.  Where a mixture has already been classified, labelled and packaged according to CHIP, and placed on the market (‘on-the-shelves’) before 1 June 2015, it does not have to be recalled for re-labelling and re-packaging.  This derogation is available until 1 June 2017. 

If these criteria are not met, mixtures placed on the market must comply with the CLP Regulation.

Note: there is no derogation for classification responsibilities.