New Regulation on Classification, Labeling and Packaging of Chemicals

The new EU regulation on classification, labeling and packaging of substances and mixtures, the so called CLP Regulation (EC) No 1272/2008 entered into force on 20 January 2009.

The CLP Regulation will gradually replace the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC). Both Directives will be repealed on 1 June 2015. The new regulation is based on the UN GHS of classification, labeling and packaging of chemicals. It defines a transitional period during which companies need to come into line with the new regulation:

As with the previous legislation, the CLP Regulation is intended to be primarily a self-classification system for enterprises. It stipulates that after entry into force the deadline for

• Substance classification (according to the CLP rules) is 30 November 2010, and for
• Mixture classification (according to the CLP rules) is 31 May 2015.

The CLP Regulation as published in the Official Journal of the European Union is available at the EURLEX website.

June 17th Conference on CLP:  The European Commission organized a conference on EU and world-wide rules for classification, labeling and packaging of chemicals. The conference aimed to inform authorities, industry and other stakeholders about the new CLP regulation in the EU, which is based on the UN GHS. It explained the main features of the new legislation, focusing on practical aspects. It provided up-to-date information on the CLP guidance documents and tools. You can access a video recording of the conference along with presentation slides on the Commission's website.

What is CLP?

The CLP regulation will require companies to classify, label and package chemical substances and mixtures according to new rules, in addition to notifying the European Chemicals Agency (ECHA) of their classification. The new act will complement the REACH Regulation on the registration, evaluation, authorization and restriction of chemicals.

There are some implications of switching between the CLP and the two directives it replaces (Dangerous Substances and Dangerous Preparations.) Some new classification criteria will cause substances to be classified more strictly than before. The total number of classified substances will remain similar, but the total number of classified mixtures will increase under the CLP regulation.  A few substances that were not covered under DSD or DPD will be covered under CLP including certain explosives, flammable aerosols and self-heating substances. Other changes will include new pictograms, hazard statements and categories for classification.

What are the issues for U.S. companies?

• Certain substances will be more severely classified and more mixtures will be classified
• Companies may have to reclassify, re-label and repackage products, along with making changes to current Safety Data Sheets (SDS)
• A change of classification under CLP can lead to new responsibilities under REACH

Guidance

Guidance is currently being developed by ECHA to help companies fulfill their obligations under CLP and apply the new rules for classification, labeling and packaging. Once published, it will be made available on ECHA’s website.

A detailed question and answer report on the CLP Regulation published by the European Chemicals Agency can be found here.

Harmonized classification and labeling

Under the CLP Regulation Member States may send proposals for the harmonized classification of substances that are carcinogenic, mutagenic, and toxic for reproduction or respiratory sensitizers. Industry can also in certain cases send proposals. For more information, click here.

Notification to ECHA

The CLP Regulation requires that companies notify the European Chemicals Agency of the classification for substances. EU Importers will submit information to ECHA on behalf of U.S. exporters. Importers will use the REACH-IT system for submitting information, which is currently under development.

For answers to frequently asked questions about REACH-IT, click here.

For more general information on inquiries, registration and creation of a joint submission, click here.

Helpdesks

Helpdesks are to be established in each Member State to assist companies - especially SMEs - to understand their new roles and duties.

For a list of national helpdesks including detailed contact information, click here.