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EU CLP Regulation (EC) No 1272/2008 PDF

What is the EU CLP Regulation (EC) No 1272/2008?

The EU CLP Regulation (EC) No 1272/2008 aims to ensure a high level of protection of human health and the environment. It also seeks to guarantee the free movement of substances, mixtures, and certain articles within its scope.

CLP stands for:

  • Classification (C): Determining the hazards of a substance or mixture and assigning it to hazard classes and categories.
  • Labelling (L): Communicating the hazards of products to users through standard pictograms and hazard statements.
  • Packaging (P): Ensuring that hazardous substances are supplied in secure, leak-proof packaging to protect consumer health and the environment.

What Is the Scope of the EU CLP Regulation (EC) No 1272/2008)?

Which product groups are excluded?

The EU CLP Regulation applies to nearly all substances and mixtures, including substances placed on the market or registered via REACH, hazardous polymers and formulations and pesticides and biocides. However, there are some exemptions, which are listed below:

  • Radioactive substances and mixtures covered by legislation on protection against ionising radiation
  • Substances and mixtures under customs supervision in temporary storage, in a free zone, or in transit, provided they are not subject to any treatment or processing
  • Non-isolated intermediates
  • Substances and mixtures used for scientific research and development under controlled conditions and not placed on the market
  • Waste, as defined under the Regulation, that is not considered a substance, mixture, or article
  • Human medicinal products and veterinary medicinal products
  • Cosmetic products
  • Medical devices in the finished state intended for the final user, which are invasive or used in direct physical contact with the human body
  • Food and feed, including additives, flavourings, and animal nutrition products

What is legally required on packaging and labelling under the EU CLP Regulation?

The main obligations introduced by the EU CLP Regulation are summarised below:

Classification obligation Substances and mixtures must be classified in accordance with the Regulation. All available information must be collected and assessed for adequacy and reliability before classification. Necessary tests must be carried out to determine hazards; testing on animals must be used only as a last resort. Classifications must be updated without undue delay where required.  
Labelling obligation The packaging of a substance or mixture classified as hazardous must include supplier details, product identifiers, hazard pictograms, signal words, hazard statements, and precautionary statements. The label must be written in the official language(s) of the Member State where the product is placed on the market. Labels must be updated without undue delay when necessary.
Packaging obligation Packaging must be designed to prevent the contents from escaping and must be made of durable materials. For hazardous products supplied to the general public, packaging must not have designs that may attract children. Certain hazard classes require child-resistant fastenings and tactile warnings of danger.
Notification obligation Manufacturers and importers must notify the classification and labelling information of substances they place on the market to ECHA within one month after placing the product on the market.
Retention and submission of information Suppliers must retain all information used for classification and labelling purposes for at least 10 years after the last supply of the product. Upon request by competent authorities of Member States or ECHA, suppliers must provide this information.
Provision of information for emergency health response Importers and downstream users must submit harmonised information on the composition of mixtures they place on the market to the bodies appointed by Member States, in accordance with CLP Article 45 and Annex VIII. This includes the obligation to submit information via the Poison Centre Notification (PCN) portal and to ensure that a Unique Formula Identifier (UFI) is included as part of the submission and on the product label.
Cooperation in the supply chain Suppliers must cooperate with one another to ensure compliance with classification, labelling, and packaging requirements.


Relationship Between the EU CLP Regulation (EC) No 1272/2008 and REACH

The EU CLP Regulation and the REACH Regulation are two complementary pillars of EU chemicals legislation. These two legal frameworks operate in direct connection at many technical and administrative levels.

For example, substances subject to registration or notification under REACH, even if not placed on the market, must be classified according to the criteria of the CLP Regulation. Furthermore, where manufacturers and importers have already submitted classification and labelling information as part of a REACH registration dossier, a separate notification under CLP is not required.

When performing hazard assessments under CLP, the general rules and existing data referred to in Annex XI of the REACH Regulation are also taken into account. The terminology used for identifying substances or mixtures must be fully consistent between the CLP label and the Safety Data Sheet (SDS) prepared in accordance with Article 31 of REACH. These examples illustrate the close interrelation between the two Regulations. To achieve full legal compliance, it is advisable to work with expert consultancy firms specialised in both legal frameworks.

EU CLP Regulation (EC) No 1272/2008 Compliance Process with Chemleg

If you are an exporter to the European Union, an importer, an Only Representative, or a formulator, you may have obligations under the EU CLP Regulation.

Chemleg can support you in this process with the following services:

You can contact our team by filling out the form below.