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Regulation (EC) No. 1271/2008 (CLP regulation) came into force on January 20, 2009.

 

It contains requirements for the classification, labeling and packaging of chemical substances and mixtures

according to the globally harmonized system of the United Nations (GHS).

 

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The CLP regulation applies to all member states of the EU and is directly applicable to all branches of the economy.

It obliges manufacturers, importers and downstream users of substances or mixtures to properly package, lable and classify those.

classification

Substances and mixtures are classified into specific hazard classes and categories.

 

  • physico-chemical hazard

  • health hazard

  • environmental hazard

 

Annex I contains the criteria for the classification of dangerous substances and mixtures.

 

labelling

Substances and mixtures must be labeled with the following information:

 

  • identity of the supplier

  • name of the substance or mixture and / or identification number

  • nominal amount of the product in the package

  • hazard pictograms

  • signal words for the danger level

  • hazard warnings

  • safety instructions

 

Annex I contains the criteria for the labeling of dangerous substances and mixtures.

packagings

The packaging of hazardous substances and mixtures have to:

 

  • prevent the content from escaping

  • are made of materials that will persist when in contact with the contents

  • be stable, strong and firm and

  • have lockable closures

 

In certain cases child-resistant locks and tactile hazard warnings are required.

Goals / updates

 

One of the main objectives of the CLP Regulation is to determine whether a substance or mixture has properties that lead to its classification as dangerous. 

 

With the enforcement of the European CLP regulation in January 2009, a process was set to harmonize and standardize the product notification in the European Economic Area in order to bring the protection of users in these countries to an equal level and to simlify the notification for everyone, especially for companies working across europe. 

Article 45 of the CLP Regulation contains provisions for the harmonization of the format and content of information for health-related emergencies.

 

Based on Article 45 , the European Commission carried out a review which resulted in the development of a harmonized notification procedure, which is regulated in Annex VIII of the CLP Regulation. This applies to all member states effective from 01.01.2021.

 

Central element of the harmonization is a uniform notification format (PCN). This gives the possibility of submitting notifications to ECHA via a central notification portal.

Annexes of the regulation

  • Annex I - classification and labeling requirements for dangerous substances and mixtures

 

  • Annex II - special rules for the labeling and packaging of certain substances and mixtures

 

  • Annex III - list of hazard statements, additional hazard statements and additional label elements

 

  • Appendix IV - list of safety instructions

 

  • Appendix V - hazard pictograms

 

  • Annex VI - harmonized classification and labeling of certain dangerous substances

 

  • Annex VII - translation table for classification according to Directive 67/548 / EEC for classification according to this regulation

 

  • Annex VIII - harmonized information related to health emergencies and preventive measures.

 

 

Do you need more information about the "new" Annex VIII?

In that case, give us a call or read here in the "Guidelines on Harmonized Information for Emergency Health Care".

 

 

 

 

 

 

 

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According to the CLP regulation, manufacturers, importers and downstream users of products that contain dangerous mixtures must add a unique formulation identifier to their product labels in the future. This is a special 16-digit alphanumeric code - the so-called UFI code (Unique Formula Identifier Code).

 

This code helps to identify a dangerous mixture in order to enable faster first aid by the poison control center.

This identifier, which is specific to each product formulation, creates a direct and unambiguous connection between the mixture that is placed on the market and the associated safety information.

The poison control center accesses this safety information in emergencies in order to be able to provide adequate first aid.

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The PCN (Poison Center Notification) - notification to poison information centers - is a notification procedure in which information about dangerous mixtures must be reported in the european database of poison information centers.

 

The legal basis for this is Article 45 of the CLP Regulation, which is anchored in national law via the Chemicals Act (Section 16e ChemG).

 

 

Product notifications in european PCN format can be made via the ECHA Submission Portal. Within the notification procedure, you first generate a UFI code for each mixture, which you link to the recipe via the notification and print on the label or packaging. The product notifications are made available to the responsable local authority  (BfR- germany) by the ECHA. As soon as the notification has been received by authorities companies have formally fulfilled your obligation.

 

 

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Do you need help with UFI code generation, your product notofications or do you have further questions?

We are happy to assist you at any time with advice and action on all aspects of the CLP Regulation and the rights and obligations associated with it.

 

All from a single source. Offline and online. Strategically and situationally.

Professional and competent

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