Yes the EU market is lack of consistency between different world States in relation to the information to be provided to national poison centres and the relevant format. Under Article 45 of the CLP Regulation 1272/2008 under which Member States are required to appoint a body/bodies (poison centres) responsible for receiving information from importers and downstream users placing hazardous mixtures on the market in order to provide emergency health information. A draft Regulation, approved by the EU Member States and expected to come into force in early 2017 harmonies the information which must be submitted. The harmonized requirements will apply to mixtures for consumer use from 1 January 2020, for professional use from 1 January 2021 and for industrial use from 1 January 2024. Submissions of information to poison centers made prior to these deadlines remain valid until 31 December 2024 (unless there is a change triggering a requirement to update).
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.
Information required to be changed in 2017
Under the harmonised requirements generally importers and/or downstream users will have to provide information including:
· product identifier of the mixture
· contact details of the party submitting the information
· hazard classification of the mixture
· label elements including hazard pictograms, signal words, hazard statement codes and precautionary statement codes (following the provisions of Art 17 CLP and the CLP Annexes)
· toxicology information
· composition of the mixture
· Hazardous components must be identified when present in concentrations ≤0.1% and/or in lower concentrations unless they can be shown as irrelevant for the purposes of emergency health response
· Non-hazardous components must also be indicated when present in concentrations ≤1%
· Concentration can be provided in ranges. The width of these ranges depends on the hazardous classification of the component and its concentration within the mixture
· a Unique Formula Identifier (UFI), an alphanumeric code that links information submitted to a particular mixture. The UFI must appear on the label for hazardous mixtures (unless for industrial use and/or mixtures which are not packaged alternatively in which case the UFI must appear on the SDS (Safety Data Sheet)). ECHA (the European Chemicals Agency) will develop a system to produce UFI
· updated information in certain circumstances such as where the composition of the mixture is changed.
ECHA (the European Chemicals Agency) will develop a form for electronic submission of the information. This will be made available free of charge.
Some key points to note
· What happens when you use a mixture in the production of a second mixture which is then placed on the market (a mixture in mixture) and you do not have access to full compositional information? There are specific provisions which apply here, also for group submissions and for perfumes and fragrances
· Can you supply more limited information where mixtures are placed on the market for industrial use only? Yes, where a telephone number (available 24/7) and e mail address for rapid access to additional information are provided
· What about confidential business information (CBI)? Confidentiality was raised during the consultation on the draft Regulation. CLP provides that poison centres must provide all requisite guarantees to maintain the confidentiality of the information received. Such information may only be used to meet medical demand and to undertake statistical analysis to identify where improved risk management measures may be needed. There is potentially a conflict between these provisions and more general EU legislation providing for public disclosure. The use of concentration ranges go some way to ensuring CBI can be protected. However, does this go far enough and can information submitted be protected
· For business operating across the EU, the new EU Regulation will level the playing field – uncertainty over what information must be submitted in different Member States has not been helpful. The obligations to provide information fall on “importers” and “downstream users” only. Business will have to assess how these obligations impact their own supply chains (e.g. a manufacturer of substances and mixtures selling directly to end users)
· Brexit – Despite the Brexit vote, the UK remains bound by the CLP Regulation and other EU legislation whilst it remains in the EU, including the requirement to submit the appropriate information to the relevant poison centre(s). The Government has indicated its intention to convert EU law including CLP and REACH into UK law “wherever practical” on Brexit, This means having equivalent requirements in UK law, and no doubt this new EU Regulation will help inform what those requirements should be.
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.
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
The CLP Regulation does not apply to the following chemicals which are in the finished state intended for the final user:
- medical devices
- veterinary medicines
- 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.
The word ‘Preparation’ has been replaced with the word ‘Mixture’.
There are now only 9 pictograms, all a white background with a red diamond frame with the black hazard symbol inside. All pictograms relating to transport are still governed by the Transport of Dangerous Goods Regulations.
A pdf list produced by the UNECE can be viewed below or on the Sigma Aldrich website.
Each substance will now have either ‘Danger’ or ‘Warning’ on the label, unless it is deemed of such low hazard to not require one.
- Danger = more severe hazards
- Warning = less severe hazards
Standard statement about the nature of hazard and degree of hazard of the substance. Each hazard statement has a corresponding identification code, however this may not be used instead of the written hazard statement on the packaging/safety data sheet and must only be used for reference.
A full list of hazard statements produced by the EC is available below as well as on the Sigma Aldrich website.
Brief statement to provide measure to undertake to minimise or prevent effects from physical, health or environmental hazards. These include first aid measures and can be a pictogram (see above) or a written statement.
Risk and Safety Phrases?
The hazard and precautionary statements replace all risk and safety phrases which will no longer be used. A full list of risk and safety phrases converted into hazard and precautionary statements is on the EC GHS website.
Any guidance on this website which refers to risk and safety phrases will be updated with hazard and precautionary statements in due course. All pages will contain the following guidance;
Any risk and safety phrases directly replace by hazard and precautionary statements have been added in brackets above. Some risk and safety phrases may not have been replaced and therefore have no corresponding hazard or precautionary statements.
Safety Data Sheets:
The word ‘material’ has been removed and these are now known simply as Safety Data Sheets. They must include 16 set headings;
- Hazard(s) identification
- Composition/information on ingredients
- First-aid measures
- Fire-fighting measures
- Accidental release measures
- Handling and storage
- Exposure controls/personal protection
- Physical and chemical properties
- Stability and reactivity
- Toxicological information
- Ecological information
- Disposal considerations
- Transport information
- Regulatory information
- Other information
Full details are available on the UNECE website.
All labels of substances must conform to the GHS via the CLP. Examples are given on the ECHA website with full details on the UNECE website.
Classification & Labelling Inventory:
The Approved Supply List will be replaced with the Classification and Labelling Inventory. This is a database that will contain basic classification and labelling information on notified and registered substances received from manufacturers and importers. It will also contain the list of harmonised classifications. The Inventory will be established and maintained by ECHA.
The full list of the ASL is now contained in Table 3.1 of Annexe VI of the CLP Regulation published on the European Commision website
How does this affect me in the EU and UK?
End-users will start to take receipt of substances with the new packaging from 1st December 2010 and therefore this information should be brought to the attention of all staff and students who may come into contact with such substances and/or mixtures. Any substances already in the supply chain (already on the shelf) do not need to be updated to reflect the CLP until 1st December 2012 (mixtures until 1st June 2017). In effect you will still be supplied with substances packaged in the ‘old’ style. There is no explicit requriement to re-label any current stock, however you may wish to re-label your current stock with the new system from 1st December 2010 to make sure users become accustomed to the new system and that old stock is treated in the same manner as new stock.
Guidance states that all containers should maintain the suppliers’ label. However, if you do decant into smaller containers and these are too small to usefully hold the information required, this information can be published in another manner deemed suitable, for example on a poster next to the cabinet in which the container is kept.
In the interim period until all deadline have passed, you should use the new CLP system of labelling but you may also wish to retain the ‘old’ labelling to ensure users have all the information at hand they require to work safely.
What about my COSHH risk assessments?
You should not have to re-do your COSHH risk assessments because of this new system. All risk or safety phrases will be replaced with equivalent or less severe hazard or precautionary statements. The current COSHH form ( previously known as HS1 and HS2 but replaced early 2012 with one form) on the Health and Safety Department has been updated to refer to hazard and precautionary statements as well as to risk and safety phrase until all substances have met the ultimate deadline of 1st June 2015. If you use any local variants of these forms, please update them with the new statements. To check the new hazard and precautionary statements against the old risk and safety phrase, please use the translation table below.
What about my cabinet, do I need to update the risk and safety phrases on this?
Yes, you should, in the short term, put both risk and safety phrases as well as hazard and precautionary statements on the cabinets your substances are stored in. Until full compliance has been reached, you may still take receipt of containers labelled in the ‘old’ manner (substances until 1st June 2012, mixtures until 1st June 2017) and you will most likely still have containers bought previously with the ‘old’ style labels. You should also replace the ‘old’ style pictograms (orange and black diamond) with the ‘new’ style (red diamond frame with the black hazard symbol). Downloadable pictograms are available on the UNECE website.
You can also order GHS compliant pictograms and posters from any good laboratory goods supplier.
The Storage of Hazardous Substances guidance published by the Health and Safety Department will not change in respect of the CLP Regulations as the guidance is based on the transport classification and signage which have not changed.
Does my Safe System of Work need changed?
This should be updated to reflect any new hazard and precautionary statement if the current risk and safety phrases are at a lower standard. If, however, the hazard and precautionary statements are at an equivalent or lesser level, your SSoW will still be valid and can be updated when your next periodic review is due. You can of course review all your SSoW and update them now if you wish.