The following guide provides step-by-step instructions on these tasks and supports you with your organisational obligations.

1. Obtain all of the information

The application of the CLP Regulation requires the composition of a mixture to be made public as precisely and accurately as possible. For each mixture, which is to be classified, you have to create a list of all of its constituents, including impurities and additives. Hazardous characteristics of the contents are generally of relevance to a mixture from concentrations of ≥ 0.1 % and/or 1 % (depending on the classification). In individual cases which involve particularly serious properties, even lower concentrations are to be taken into account.

The list on the composition should contain the following:

• the identity of the constituents,
• their appropriate concentration in the mixture,
• the classification of the substances according to the CLP,
• the accompanying H-Phrases and EUH-Phrases,
• specific concentration limit values and M-factors, if available.

The safety data sheets (SDS) are the most important source of information. If you produce a new mixture, the safety data sheets (SDS) for the constituents should be directly available to you. If you import the mixture and make it available on the European market, it can be more difficult to obtain the information, but an SDS according to different standards can nevertheless serve as a point of reference for your own research into the constituents and their properties. If you require further information, contact your supplier, and make sure that your inventory is complete:

• the previous SDS for the mixture (if available)
• the SDS for the individual constituents,
• the data gathered by the ECHA under Registered Substances,
• the Classification and Labelling Inventory (C&L Inventory),
• the Dangerous Goods Database by the BAM,
• chemical information system of the federal government and the Länder (ChemInfo)
• GESTIS Substance Database by the Institute for Occupational Safety and Health (IFA) of the German Social Accident Insurance (DGUV),
• eChemPortal by the OECD

2. Review the information

Find out which properties of the constituents can affect the classification of your mixture. Differentiate between health, environmental and physical hazards.

Make sure that you have all the information which you require for a correct and comprehensive classification of the mixture according to the criteria in Annex I of the CLP Regulation. Are test data available for the mixture or do you have to access the results concerning the constituents? Is the information compatible or does it raise questions?

Make sure that you ascertain the extent to which a harmonised classification (also known as a "legal classification") is available for the constituents of your mixture, and also make sure that it has been transferred correctly to the mixture. Detailed information on the substances is available in the database of the ECHA. From the so-called “brief profile” of the individual substances, you can access the C&L Inventory via a link. You will find the harmonised classification in the light blue section at the top. The information and conditions from this area are to be applied directly to your mixture.

With the help of the yellow area in the C&L directory, you should also check whether it is necessary to take further hazard categories, which have not yet been harmonised into account. At the same time, please note that these entries are based on reports from manufacturers or importers and have neither been checked nor coordinated. These entries can also raise questions. Further information is available at so-called “joint entries” for which a registration dossier is usually available, which also contains key test data. These can be found in the "brief profile" of the ECHA under the "Regulatory context" and "registrations under REACH".

For mixtures, the assessment of the available information can be a challenging task, particularly if it is not possible to apply the criteria directly to the available data. Is it possible that your range of products contains similar mixtures, e.g. as extracts of natural substances, whose data you want to refer to? This procedure is known as “Bridging”. For borderline cases, you require an evidence-based approach which requires expert knowledge. Therefore, make sure you have the necessary professional support!

3. Evaluate the data

The evaluation of the physical hazards is generally based on test data which has to be gathered for the mixture itself. Calculation methods are only available in a few cases, primarily with gases. For obvious questions (e.g. the flammability of aqueous mixtures) it may be possible to decide whether a test is actually necessary on the basis of the mixture's composition. Some of the study requirements have changed as a result of the CLP Regulation, which means that the corresponding tests have to be carried out again. With a little effort, it is possible that considering the background to a transport classification may also be of help. Make sure that you have access to all of the relevant study results.

Studies with the mixture can be of value for the classification regarding health hazards, but this is rarely the case. The results concerning the constituents are of particular importance. To make sure that you maintain an overview, gather all of the facts together with care, ideally on the basis of the sub-section in part 3 of Annex I of the CLP Regulation. Important: keep a record of what you do! If the information in the SDS is insufficient, you should conduct research into further facts in the relevant public databases and at the ECHA. Use the expert knowledge for the evaluation of the available data, particularly if they are incomplete. For animal welfare reasons, no further tests will be carried out.

Environmental hazards are described on the basis of substances’ acute and chronic aquatic toxicity, recently supplemented with their endocrine-disrupting properties in the environment and their persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), or very persistent, very mobile (vPvM) properties. The evaluation of aquatic toxicity is based on the test results for the constituents which are supplemented by data on biodegradability and accumulation potential for the assessment of the long term effects. During classification, so-called multiplication factors (M-factors) give added weight to constituents which have a particularly high degree of aquatic toxicity. If the amount of data available about aquatic toxicity is limited, it may be the case that the ECHA's registration database can be of help. Otherwise, to have reliable data, you should contact your suppliers.

There may be further hazards which you need to take into account. In this respect, starting from a content of 0.1%, a constituent which is hazardous to the ozone layer leads to the classification of the mixture (see Part 5 of Annex I of the CLP Regulation). Labelling with EUH statements may be necessary, for example if your mixture releases toxic gases in contact with water, or if a specific lead content is exceeded. Further details are available in Annex II, parts 1 and 2 of the CLP Regulation. Please make sure that you do not overlook any factors which are relevant to your mixture.

4. The classification and labelling of your mixture

If a relevant study is available for the mixture itself or a comparable mixture, the result will be compared with the criteria in Annex I of the CLP Regulation and the classification will be determined. This is also relevant for physical hazards. In the case of health and environmental hazards, the content of the individual constituents are usually compared with a so-called concentration limit value, which is the threshold value for the classification of the mixture. The general concentration limits (GCLs) for the differing hazard classes and categories are stated in the relevant sections of Annex I, parts 3 and 4. There can also be specific concentration limits for substances with a harmonised classification, which are known as "SCLs" and are stated in Annex VI, part 3 of the CLP Regulation together with the corresponding substance entry. SCLs are also stated in the C&L Inventory.

For health and environmental hazards, the constituents in a mixture can either be aggregated, or each individual constituent can be considered individually. An additivity-based approach is chosen if the sum total of all constituents which have a particular property is decisive to the classification. In this respect, the different effectiveness levels of the constituents are taken into account on the basis of a weighted calculation. Typical examples of additivity include acute toxicity, irritant effect or aquatic toxicity. In contrast to this, for sensitisation, carcinogenicity, endocrine disruption for human health and for the environment, PBT- or vPvB-, resp. PMT- or vPvM-properties, the content of a specific constituent is compared directly with the appropriate threshold value without considering other substances with the same characteristics. These hazard classes are therefore examples of non-additivity.

Please note: As a result of the CLP Regulation, certain evaluation methods have been modified in comparison with the previous Preparation Directive. This can change the classification of a mixture even if the data have remained the same. Other evaluation methods do not even have equivalents in the old system, which means it is not possible to look back at it in order to classify a mixture under the CLP. To maintain a clear overview, you should configure the evaluation on a systematic basis, ideally according to the relevant section in Annex I of the CLP Regulation. The ECHA Guidance on the Application of the CLP Criteria, which is regularly updated, also provides support.

When you have reached a decision on the classification of your mixture, you must then determine its labelling. This encompasses

• Details about the supplier
• Product identifier
• Nominal quantity (in the packaging which is made available to the general public)
• Hazardous constituents
• Hazard pictograms
• Signal word
• Hazard statements (including EUH statements)
• In general, not more than six precautionary statements

The regulations on the design of the label are highly detailed and include rules regarding the size of the label and the pictograms, the wording of the H- and P-statements, and much more. Additional explanations are available under labelling elements and in the ECHA Guidance on Labelling and Packaging.

In the final step, all you need to do is to align your safety data sheet to the new classification and labelling of the mixture. Has there been a change? Then you should notify your customers accordingly! A source of help to which you should pay particular attention in the context of the SDS is the ECHA Guidance on the compilation of safety data sheets.

5. Make sure that you are always up to date

As a result of the REACH Regulation (Regulation (EC) no. 1907/2006), the options for obtaining and using information which is relevant to the classification have substantially increased and new data is being added all the time. Further information on the individual substances can affect the harmonised classification and therefore have an immediate impact on the classification of your mixture. The regulations can continue to change, however, and the classification criteria can also be adapted to technical progress. Last but not least, changes in the composition of substances or mixtures can also be made in the supply chain.

It is therefore necessary to make regular checks to see whether a change has occurred which affects the classification and labelling of your mixture. For this purpose, compile a timetable and follow it. That way, you can ensure that your classification and labelling remains up to date and that you respond quickly to new developments.

A check list for the classification / reclassification of mixtures is available as download here (in German).

For further detailed information please refer to our German Website.