Denehurst Chemical Safety Ltd CLP

The New CLP Regulation

Chemical control legislation in Europe is in the process of a significant change through the introduction of the Classification, Labelling and Packaging Regulation EC (No) 1272/2008, more commonly known as CLP. CLP came into force on 20th January 2009, replacing the Dangerous Substances Directive (DSD) 67/548/EEC and the Dangerous Preparations Directive (DPD) 1999/45/EC.

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 3rd Edition of the GHS was published in July 2009. More information about GHS can be found on the GHS pages of 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.

The EU has also sought to retain some of the benefits from the 40 years

of experience with the DSD and DPD, which may result in 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”.

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.

CLP Requirements
A transitional timetable is in place to help suppliers move over to the new system. CLP applies to manufacturers and importers, and some distributors and downstream users (formulators who mix products are considered to be downstream users.

• Substances have been required to be classified and labelled to CLP since 1 December 2010. To help with products that were already in the supply chain on this date, a further 2 years transition period, until 1 December 2012, is available for substances that were already classified, packaged and labelled according to the DSD, and placed on the market (i.e. they were already “on the shelf” before 1 December 2010).
• Since 1 December 2010, manufacturers and importers of substances subject to REACH registration requirements, hazardous substances and hazardous components of hazardous mixtures, must also submit a notification of the classification and labelling to the European Chemicals Agency (ECHA) within 1 month of placing the substance on the market, unless this information had already been supplied as part of a valid registration under REACH.
•Mixtures need to be reclassified and relabelled by 1 June 2015. Similarly to substances, a further 2 years transition period, until 1 June 2017, is also available for mixtures that are already classified, packaged and labelled according to the Dangerous Preparations Directive (DPD), and placed on the market (i.e. they are already “on the shelf”) before 1 June 2015.

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. More information about notificaiton is available here.

How does CLP differ to the DSD and DPD?
Although the two systems look very different at first sight, they 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 included those substances included in the DSD up until the 29th ATP. The 30th and 31st ATPs to the DSD have now been incorporated into CLP through the 1st ATP to this Regulation, which was published on 5th September 2009.

During the translation process between the two sets of legislation, some changes have been made to these harmonised classifications. In particular, the specific concentration limits for a number of substances have been removed where these were identical to the generic concentration limits under the DPD. Specific concentration limits for acute toxicity have also been removed, as a different method for assessing the acute toxicity of mixtures is used under CLP.

A number of errors in the translation of Annex VI have been identified, and will be addressed in future updates to CLP. In the meantime, the list of known 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 can also now submit requests for harmonised classification, except for biocide or plant protection product actives which can only be submitted by Member State competent authorities.

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 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.

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 cut-off

values used to classify mixtures mean that one to one translations may not be valid.

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.

Labelling changes
A number of labelling elements have changed under CLP. There are new pictograms; 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, and further guidance is available in the Guidance on Labelling and Packaging in Accordance with the CLP Regulation.

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) are also affected by CLP, which includes amendments to REACH Article 31 and Annex II. Further amendments to align EU SDS with the GHS were also introduced through amendments to Annex II of REACH.

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.

This page was last updated on 3rd February 2012