Chemicals e-book Flashcards
Legislation
The Classification, Labelling and Packaging of substances and mixtures regulations (CLP) came into effect in January 2009 and fully replaced the previous CHIP regulations in June 2015.
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 member
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.
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 Health and Safety
Executive (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 and the Scottish Environmental Protection Agency, provide technical and scientific support.
Indications of particular risks and special precautions: The hazard label
A hazard label is made up of the above symbols (‘pictograms’) and warnings. These pictograms and the wording that supports them are set out in law and chemical suppliers must use them where hazardous properties have been identified.
Suppliers must label a substance or mixture contained in
packaging according to CLP before placing it on the market either when:
• A substance is classified as hazardous.
• A mixture contains one or more substances classified as
hazardous above a certain threshold.
In addition to the warning symbol, under the CLP regulations chemicals are required to display on the label indications of particular risks e.g. irritating to eyes, harmful if swallowed, explosive when mixed with a combustible material.
Also under the CLP regulations chemicals are required to display safety precautions. Examples of these include: keep out of reach of children, wear suitable protective clothing, and never add water to this product.
The CLP regulation introduces two new signal words: ‘Danger’ and ‘Warning’.
If the chemical has a more severe hazard, the label includes the signal word ‘Danger’; in case of less severe hazards, the signal word is ‘Warning’.
CLP labelling requirements include:
• Name and Address and telephone number of Supplier
• The nominal quantity of the substance or mixture in the
package where this is being made available to the general public, unless this quantity is specified elsewhere on the package;
• Product identifiers;
• Hazard pictograms, where applicable;
• the relevant signal word, where applicable;
• Hazard statements, where applicable;
• Appropriate precautionary statements where applicable;
• A section for supplemental information, where applicable.
• Language must be in English unless supplying to an EU
state, when it has to be in the language of that state
• Clearly stated
• Indelibly marked
• The colour of the label and markings must be such that the symbols required stand out
• The wording size and spacing must be easily read
• The particulars must be able to be read horizontally
• The label must be a certain size
• The EC number and EC label (if a substance in part 3 of
table 3.2 of Annex VI of the CLP regulations)
Data sheets
Data sheets are required to be provided with chemicals which are subject to the REACH (registration, evaluation, authorisation and restriction of chemicals) regulations, when they are supplied for the first time in connection with work. This might include supply to a doctor for use in their practice. This is to ensure that the recipient can take any necessary precautions. The supplier must ensure that the data sheet is kept up to data and revise in line with new health and safety information. Data sheets do not need to be given when supplies are made to the general public.
Packaging requirements
In short, such package should:
• prevent escape of the chemical;
• not be adversely affected by the chemical; and
• be strong enough to withstand normal handling.
In addition, if the package has a replaceable closure this must continue to prevent escape even after repeated use.
‘Child resistant’ closures/fastenings and/or ‘tactile warnings’ (raised-profile warnings that can be understood by those with impaired vision) are also required in some cases.
Chemicals and podiatrists
chiropodists and podiatrist use several chemicals in their practice. Such chemicals may fall outside the definition of medicinal product. If they are placed on market with medicinal claims, they are regulated as medical devices.
There is a need for a quality assurance system when such chemicals are used on patients. Suppliers are encouraged to use the CE mark.
Explosive Precursors
Since May 2015 the Deregulation Act 2015 brought into effect changes to poisons legislation, including the abolition of the Poisons Board, and the removal of the Poisons List and almost all of the poisons schedules.
Listed sellers, part 1 and part 2 poisons, householder
certificates and many of the other provisions formerly
associated with poisons are no longer applicable, and a new, less complicated system of control is now in place.
‘Regulated substances’ include Part 1 and Part 2, i.e.
regulated explosive precursors and regulated poisons.
Members of the public who want to acquire or import these chemicals must hold a licence issued by the Home Office and an associated photographic identity document, e.g. passport or photographic driving licence.
From 2 March 2016, members of the public who want to
possess or use these chemicals must hold a licence issued by the Home Office and an associated photographic identity document.
Schedule 1A of the newly amended Poisons Act lists
substances controlled under the new legislation. It
consists of four parts, defining four types of substances:
- Part 1: regulated explosive precursors
- Part 2: regulated poisons
- Part 3: reportable explosive
- Part 4: reportable poisonsm
A regulated substance must only be supplied to
A regulated substance must only be supplied to a member of public from a registered pharmacy by or under the supervision of a pharmacist. The details of the sale must be entered onto the licence, and the seller must also keep records of the sale stating:
The date of supply
The name and address of the purchaser
The name and quantity of the regulated poison supplied
The stated purpose of the purchase
The purchaser must sign this record.
Substances listed in Part 3 and Part 4 do not
Substances listed in Part 3 and Part 4 do not require the
purchaser to hold a Home Office licence. They can be
supplied if the request is not suspicious and after considering whether more appropriate commercial alternatives and sellers are available.
In Part 1: Regulated explosive precursors the chemicals
involved include:
- hydrogen peroxide:12% w/w
- nitromethane: 30% w/w
- nitric acid: 3% w/w
- sodium chlorate: 40% w/w
- potassium chlorate: 40% w/w
- sodium perchlorate: 40% w/w
- potassium perchlorate: 40% w/w
Part 3: Reportable explosive precursors. Pharmacists should report suspicious interest in these substances:
- ammonium nitrate
- acetone
- hexamine
- sulphuric acid
- potassium nitrate
- sodium nitrate
- calcium nitrate
- calcium ammonium nitrate
Products of particular interest are those in which a reportable chemical is either:
• present on its own or the main ingredient
• present in a simple mixture, typically less than five
ingredients
Products containing less than 1% of any of the reportable
chemicals, or fertilizers that are not labelled for nitrogen (N) content are, in general, of no concern.
Chemical - May be present in
Hydrogen peroxide -Bleach, hair bleach, disinfectants, cleaning agents
Nitromethane - Fuel for model engines
Nitric acid - Etching agent, metal treatment
Sodium chlorate, potassium chlorate, sodium perchlorate
and potassium perchlorate - Pyrotechnic kits
Ammonium nitrate - Fertilizer, cold packs
Acetone - Nail polish remover, solvent
Hexamine - Solid fuel for camping stoves and model steam engines
Sulphuric acid - Drain cleaner, acid for car batteries (sold as such)
Potassium nitrate, sodium nitrate and calcium nitrate - Fertilizer, food preservative (sold as such)
Calcium ammonium nitrate - Fertilizer
What is REACH?
REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) is the system for controlling
chemicals in Europe. It became law in the UK on 1st June 2007. REACH adopted some of the older aspects of the chemicals system in Europe, including Safety Data Sheets (SDS).
Previously, under the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (CHIP) suppliers of substances or mixtures meeting the criteria for classification as dangerous have been required to compile and supply a SDS at the first delivery of a substance or mixture. REACH took over this system and it has now been changed to take into account the new Classification, Labelling and Packaging (CLP) Regulation.
