The CLP Regulation

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The CLP Regulation

The Classification, Labelling and Packaging Regulation EC (No) 1272/2008, more commonly known as CLP came into force on 20^th January 2009 and will replace the Dangerous Substances Directive (DSD) 67/548/EEC and the Dangerous Preparations Directive (DPD) 1999/45/EC.

This page provides an overview of CLP. More information on the Classification and Labelling Inventory can be found here and advice on submitting a CLP notification can be found here.

This page was last updated 08 February 2011.

CLP Implements GHS
CLP implements the Globally Harmonised System (GHS) of Classification and Labelling of Chemicals into the European Union. Development of the GHS began following the 1992 Rio de Janeiro UN Conference on Environment and Development with the aim of providing a consistent, harmonised system for the identification and communication of hazards about chemicals, so as to enable their safe use, transport and disposal. The first edition of the GHS was eventually published in 2002, and regular updates have been published since, on an approximately 2 yearly basis. The 3^rd Edition of the GHS was published in July 2009. More information about GHS can be found on the UNECE website.

The GHS is a model regulation and as such, has no legal status. It must be implemented in each country or region by appropriate legislation. Many countries have adopted, or are in the process of adopting the GHS into their regulatory systems. Further information on the progress of these countries, together with links to relevant national legislation is available here. International transport rules are also aligned with GHS.

CLP is not the same as GHS
The GHS is based upon a “building block” approach, allowing countries to select those elements they believe to be most relevant. In the EU, only those building blocks that most closely match the DSD and DPD system have been incorporated into CLP. This may result in different classifications for some products in the EU compared to other parts of the world.

Through CLP, the EU seeks to retain some of the benefits from the 40 years of experience with the DSD and DPD, which may result in further differences between the way that GHS is implemented in CLP and the way it is being implemented in other countries.

CLP includes some additional classification elements from the DSD and DPD which are not yet included in the GHS. These additional requirements are sometimes referred to as the “EU Leftovers”.

EU Leftovers
EUH059 — Hazardous to the Ozone Layer*
EUH001 — Explosive when dry
EUH006 — Explosive with or without contact with air
EUH014 — Reacts violently with water
EUH018 — In use, may form flammable/explosive vapour-air mixture
EUH019 — May form explosive peroxides
EUH044 — Risk of explosion if heated under confinement
EUH029 — Contact with water liberates toxic gas
EUH031 — Contact with acids liberates toxic gas
EUH032 — Contact with acids liberates very toxic gas
EUH066 — Repeated exposure may cause skin dryness or cracking
EUH070 — Toxic by eye contact
EUH071 — Corrosive to the respiratory tract

*EUH059 – Hazardous to the Ozone Layer has now been incorporated into the 3^rd edition of the GHS, which will be incorporated into CLP through the 2nd ATP (Adaptation to Technical Progress) which is expected in 2011.

CLP also includes some special phrases to be added to labels for certain types of mixtures, and requirements for child resistant packaging and tactile warnings. These have been brought through from the DSD and DPD.

CLP Requirements
CLP will require manufacturers and importers, and some distributors and downstream users (formulators who mix products are considered to be downstream users) to reclassify and relabel their substances and mixtures according to CLP. In addition, manufacturers and importers will need to submit a notification of the classification and labelling of their substances to ECHA within one month of placing them on the market.

The timetable for CLP implementation is well under way, and substances should have been reclassified and relabelled by 1 December 2010, unless the two year transitional period for substances that are already on the market is being applied. In this case, substnaces that have already been classified, packaged and labelled, and placed on the market (i.e. they are already “on the shelf”) before 1 December 2010 need not be relabelled until 1 December 2012.

For mixtures a further 4 years until 1 June 2015 are available before they must be reclassified and relabelled. To help with products already in the supply chain, a further 2 years transition period, until 1 June 2017, is also available, as for substances. This transitional period will apply to mixtures that are already classified, packaged and labelled, and placed on the market (i.e. they are already “on the shelf”) before 1 June 2015.

In addition to reclassifying and relabelling their products, manufacturers and importers must also submit a notification to the European Chemicals Agency (ECHA) of the classification and labelling of their substances, unless this information has already been supplied as part of a valid registration under REACH. Note that for imported mixtures, notification may also be required for component substances in the mixture, if the mixture is classified as hazardous. More information on what must be notified can be found here. Unlike the REACH Registration requirements, CLP applies to ALL substances and mixtures irrespective of the volume supplied. This means that notifications to ECHA will be required for substances manufactured or imported in small quantities, as well as those manufactured or imported in quantities greater than one tonne per year. The initial deadline for notification has now passed, and notifications for new substances that are manufactured or imported for the first time should be made within one month of placing the susbtance on the market.

How does CLP differ to the DSD and DPD?

Although the two systems look very different at first sight, they also have many similarities, for example:

they cover approximately the same hazards of a substance or mixture
they use similar or equivalent classification criteria, and
they communicate these hazards through the provision of information on labels and safety data sheets

However,

there are some terminology changes, e.g. ‘mixture’ instead of ‘preparation’
some new hazard classes and categories are introduced
some classification criteria are different or use different cut-offs
mixtures are handled differently
some labelling elements are changed

Classification criteria changes

CLP allows for two types of classification:

harmonised classification, in which the classification and labelling of a substance is agreed at EU level; and
self classification where the substance or mixture is classified by the supplier.

Harmonised classification

The system of harmonised classification introduced through the DSD has been transferred to CLP, and the existing classifications from Annex 1 of the DSD have been transferred to Annex VI of CLP, together with their new CLP equivalents. Annex VI, as first published only includes those substances included in the DSD up until the 29^th ATP. The 30^th and 31^st ATPs to the DSD have now been incorporated into CLP through the 1^st ATP to this Regulation, which was published on 5^th September 2009.

During the translation process between the two sets of legislation, some changes were made to these harmonised classifications. In particular, the specific concentration limits for a number of substances were removed where these were identical to the generic concentration limits under the DPD. However, these generic concentration limits are not always the same under CLP, which effectively meant that a number of products needed immediate reclassification.

A number of errors in the translation of Annex VI have also been identified, and will be addressed in future updates to CLP. In the meantime, the list of knwon errors can be found on the ECHA website here.

In future, new harmonised classifications will focus chiefly on CMR effects, and on respiratory sensitisation. Harmonised classifications will normally only be made for other endpoints on a case by case basis. This will mean that companies using these harmonised classifications will need to consider all other endpoints and self-classify for these. New harmonised classifications for active biocides and plant protection substances, however, will normally cover all hazard end points.

A new feature of CLP is that, as well as Member State competent authorities, companies will also in future be able to submit requests for harmonised classification, except for biocide or plant protection product actives which can only be submitted by Member State competent authorities. However, it should be noted that a fee will be payable to ECHA should such a request be made.

Self classification

There has been a significant increase in the number of hazard classes and categories between the DSD/DPD and CLP, particularly for physical hazards, which have increased from 5 to 16 categories, and are now much more closely aligned with transport requirements. The criteria for classification into these hazard classes are also often different. One advantage of the CLP system however, is that it offers a greater degree of flexibility for classification of products than the DSD and DPD, with more opportunity for those involved to exercise professional judgment when the classification criteria cannot be directly applied to the available data. CLP also introduces the concept of bridging principles, which allow the use of test data for similar mixtures to be applied to new mixtures.

Annex VII of CLP provides a translation table between the old DSD/DPD classifications and CLP to help companies carry out the reclassification of their products when there is no data available to allow classification from first principles. However, there are a number of limitations to its use, and these must be taken into account when deciding how to make use of it. Detailed guidance on the use of the translation table is provided in the new Guidance on the Application of the CLP Criteria.

It should not be assumed that only those products currently classified as hazardous will need reclassification. Changes in the classification criteria, and particularly in the way that mixtures are assessed, may mean that some products not currently classified as hazardous will become classified as hazardous using the new approach.

Physical Hazards

The classification criteria for physical hazards within the GHS, and therefore CLP, were largely based upon those of the UN Recommendations on the Transport of Dangerous Goods (commonly known as the Orange Book). Although the Orange Book addresses roughly the same hazards as the DSD/DPD, e.g. explosivity, flammability, oxidising potential, etc., the test methods and classification criteria for these hazards are often significantly different. This means that a one-to-one translation of hazards between the DSD/DPD and CLP is often not possible.

In most cases companies will have performed classifications of their products for transport, so should have sufficient information available to help them reclassify to the new system. Such information does not necessarily have to include test data – it may be possible to use the so called bridging principles, or to use data obtained by use of Q(SAR) models, weight of evidence, etc. However, if there is insufficient information to allow an assessment to be made for a particular endpoint, then CLP imposes an obligation on the supplier to carry out new testing for physical hazards. From 2014, new testing for physical hazards will need to be carried out to a recognised quality standard.

Health and Environmental Hazards

For health and environmental hazards there is perhaps a greater similarity between the endpoints and test methods of the DSD/DPD and CLP than physical hazards, allowing a greater degree of translation of hazards between the two systems. However, before carrying out such translation it is important that the differences between the two systems are well understood, and professional judgment exercised as to when such translation is appropriate and when it is necessary to carry out a full reassessment. Such caution is particularly needed for mixtures, where differences in the calculation methods and concnetration limits used to classify mixtures mean that one to one translations may not be valid.

In particular, changes in the concentration limits for classification as corrosive and irritant, and as hazardous for reproduction are amongst the changes, and are likely to mean that many more mixtures will be classified as hazardous under CLP than were classified under the DPD.

A more detailed look at the differences between the classification criteria of the two systems for health and environmental effects can found at http://ec.europa.eu/enterprise/reach/docs/ghs/ghs_comparison_classifications_dec07_en.pdf

A key difference between the health and environmental hazards, and the physical hazards, is that where there is insufficient information to classify for a particular endpoint, then CLP does not oblige suppliers to carry out new testing. CLP makes clear that new testing involving animals should only be carried out as a last resort. Any decisions on new testing should also take into account REACH obligations for the product.

CLP	DSD/DPD	Hazard
		Explosive Self Reactive Organic Peroxide
		Flammable Gases Flammable Aerosols Flammable Liquids Flammable Solids Pyrophoric	Self-Reactive Self-Heating Contact with water, emits flammable gas Organic peroxide
		Oxidizing gases Oxidizing liquids Oxidizing solids
		Gases under pressure
		Corrosive to metals
		Acute toxicity Very toxic (Fatal) Toxic
		Corrosive (causes severe skin burns and eye damage) Serious eye damage
		Respiratory sensitiser Mutagen Carcinogen Reproductive toxicity Systemic Target Organ Toxicity Aspiration hazard
		Acute toxicity Harmful Skin irritation, Serious eye irritation, Respiratory irritant Skin sensitiser Narcotic
		Acute Hazard Chronic Hazard

Labelling Changes
A number of labelling elements have changed under CLP. There are new pictograms (illustrated above); the descriptive Indications of Danger, such as “Flammable” and “Harmful” are replaced by the simpler Signal Words “Danger” and “Warning”; and Risk and Safety Phrases are replaced by Hazard Statements and Precautionary Statements. In many cases these new phrases are very similar to the old phrases, but there are also many new phrases, particularly for the Precautionary Statements.

Following the GHS, and CLP, criteria, many substances and mixtures will be assigned a large number of Precautionary (P) statements –often 20-30 or even more if the product has several hazards. The CLP Regulation, following on from the normal practice under the DSD and DPD recommends that normally no more than six P statements should appear on the label. Selection of these P Statements may be a complex process for some products, as there is currently no guidance on the use of each individual Statement, as there was for the Safety (S) Phrases. This is an issue that is currently under discussion at the level of the UNECE Subcommittee of Experts on the GHS. Until this issue is resolved at this level, an interim strategy has been proposed in the Guidance, based on the Safety Phrase guidance, together with consideration of the product packaging and use to assist suppliers in their selection.

Labels

Labels under CLP must include the following elements:

name, address, telephone number
nominal quantity for packages available to public, unless elsewhere on the package
product identifiers
hazard pictograms
signal words
hazard statements
appropriate precautionary statements
supplemental information

There are many similarities in the arrangement of labels, e.g. obligatory elements must be located together, and there are minimum sizes for labels and pictograms. Additional information required by, for example, the BPD or VOC legislation is considered to be ‘supplemental information’ for the purposes of labelling. For multilingual labels, the hazard and precautionary statements need to be kept together for each language.

A number of challenges will be faced in the design of new labels. The new pictograms, which are diamond shaped, rather than rectangular, will take up more space on the labels, as it is difficult to make text flow around them. It is also possible for products to attract up to 5 or 6 hazard pictograms, compared to a maximum of 4 under the DSD and DPD. Furthermore, many of the new hazard and precautionary statements are longer than the old risk and safety phrases, again requiring more space on the label. These issues are expected to particularly challenge suppliers trying to maintain the readability of labels for small packages, and also packages with multi-lingual labels.

Safety Data Sheets
Safety Data Sheets (SDS) will also be affected by CLP, and these changes have been incorporated into the revision of REACH Annex II, which is disucssed in more detail here.

Once the product is relabelled in accordance with CLP, the new classification, including the label elements, will need to be included in section 2 of the SDS. The CLP classifications of significant components will also need to be included in section 3. Any change in the classification will also need to be reflected in the information provided in other sections of the SDS. These classifications should be consistent with the new Classification and Labelling Inventory once that becomes available.

Where suppliers move to the new CLP classifications before the end of the relevant transition period, they will need to continue to show the DSD/DPD classification as well. For substance suppliers, the DSD classification needs to be included until 1 June 2015, to assist formulators, etc. downstream who may still be classifying their mixtures using the DPD. This applies to new substances as well as existing substances. This effectively means that classification to both sets of requirements will be needed until 1 June 2015, and the SDS will need to show both sets of information.

If a supplier wishes to include the CLP classification before the product labelling is changed, the Guidance recommends that this information is added to section 16 to avoid confusion.

Knock on effects of classification changes
There are approximately 20 downstream Directives and Regulations which rely on the classification of substances and mixtures under the DSD/DPD, and hence CLP. If a product changes classification, there may be impacts for the supplier from this additional legislation. This might include sites becoming subject to COMAH, or moving from lower to top tier status; protective equipment requirements and working practices; impacts on disposal of waste products, etc.

How do I implement CLP

There are a number of key stages to think about when implementing CLP. These include:

• Identifying your role under CLP

The term “manufacturer” has a specific meaning in both REACH and CLP, and is used for the person making a substance. Formulators who mix substances are considered to be downstream users. Whilst both manufacturers and downstream users have obligations to properly classify and label their products, manufacturers of substances also have some additional obligations, in particular an obligation to notify ECHA of the classification and labelling for their substance(s).

• Identifying the products that need reclassification

Most companies will already have developed a detailed inventory of their products for the purposes of REACH, and this document will provide a good starting point for identifying those products in need of reclassification. You should not assume that only those products currently classified as hazardous will need reclassification. Changes in the classification criteria, and particularly in the way that mixtures are assessed, may mean that some products not currently classified as hazardous will become hazardous under the new approach. You will also need to consider products manufactured or imported below the 1 tonne threshold.

• Deciding how will you go about reclassifying

Companies will need to decide who will carry out the reclassification, and what resources may be needed to do this. If you are going to do this in house, you will need to train your staff in the new requirements. If your staff use software tools to help them, you may need to invest in upgrading these to make sure they fully cover the new requirements. Alternatively, you may decide to use an external consultant to help you. In this case, you should make sure that they have the right skills to help you, and also the necessary resources, as deadlines approach.

• Deciding when to implement the new classifications

CLP imposes deadlines for reclassification, of 1 Dec 2010 for substances and 1 June 2015 for mixtures. However, many products will be in the supply chain for a long time, and you should not wait until the last minute to make these changes. On the other hand, awareness of the new labels will be low amongst customers in the early days, and you may have to spend some time educating your sales force and customers on the changes.

If you are a downstream user (formulator) you will also need to decide whether to wait until the component ingredients in your mixture have been reclassified by your supplier. You may wish to start contacting your suppliers to find out what their plans are, and whether they anticipate any changes in the classification of their products under CLP

You should also take into account any REACH obligations you may have, and try to plan CLP to fit in with these.

• Consider any knock-on effects

If any of your products change classification, you may need to change your packaging.

You should also consider the impact on other downstream legislation, for example, how you protect your workers, how much product you may store on your site, and how you dispose of waste material.

Getting started

A useful first step may be to carry out a private run through of your products, using the translation table to help you identify those products and components which may require particular attention in the reclassification process. Do not forget to include any substances currently classified as non-hazardous which may be reclassified under the new system.

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This page last updated 08 February 2011