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EU CLP

On 20 January 2009, the CLP Regulation EC No 1272/2008 (regulation on classification, labelling and packaging of substance and mixtures) entered into force in the EU. This is the European equivalent of the UN GHS. This classification system aims to further protect humans and the environment from the effects of hazardous materials and to facilitate trade while complementing the REACH Regulation.

The initial EU CLP Regulation followed GHS as close as possible, but it is different from the UN GHS as the EU wanted also to remain as close as possible to the Dangerous Substances (67/548/EC) and Dangerous Preparations (1999/45/EC) Directives while respecting REACH. This ment that: 

  • Based on the  so-called UN GHS "building block approach" CLP did not take over all hazard categories for a hazard class because they were not part of DSD, e.g. category 4 of the hazard class flammable liquids, or category 3 (mild irritant) of the hazard class skin corrosion/irritation.
  • CLP does contain hazard categories not part of GHS (e.g., ozone depleting substances, EUH014(‘Reacts violently with water), EUH066(Repeated exposure may cause skin dryness or cracking)) to retain the same level of protection.
  • The CLP includes special labelling and packaging rules that are not part of the UN GHS, but are coming from the DSD and DPD, e.g., the rules on small packaging (CLP Article 29), on supplemental information for certain mixtures (Part 2 of Annex II to CLP) and for the provision of child-resistant fastenings or tactile warnings. Also, it includes rules for the situation when a substance is both covered by CLP and by transport legislation (CLP Article 33)
  • The CLP text is amended via Adaptations

The CLP includes some additional processes:

 Harmonised classification and labelling

The classification and labelling of certain hazardous chemicals are harmonised to ensure adequate risk management throughout the EU. Member States and manufacturers, importers or downstream users may propose a harmonised classification and labelling (CLH) of a substance. However, only Member States can propose a revision of an existing harmonisation and submit CLH proposals when a substance is an active substance in biocidal or plant protection products. The steps of the harmonised classification process are well outlined on the ECHA websit: here

Industry is invited to contribute to the CLH process at several steps

  • A CLH process begins when ECHA receives an intention to prepare a CLH dossier by an MSCA or manufacturer, importer or downstream user. Anyone with information relevant to the proposed hazard classification for a substance may bring this to the attention of the party submitting the CLH proposal during the early stages of the process.
  • After the CLH dossier has been submitted to ECHA and it fulfilled the accordance check done by ECHA (i.e., does the dossier fulfil the legal requirements of CLP, does it include the information needed for ECHA’s Risk Assessment Committee (RAC) to deliver an opinion on the proposed classification?) ECHA will organise a Public Consultation for 60 days. All interested parties are invited to comment on those hazard classes for which data has been provided in the CLH dossier. Comments received are published on ECHA’s website and will be forwarded to the Dossier Submitter, who will prepare a response to the comments (RCOM) documents.
  •  ECHA’s Risk Assessment Committee will develop an opinion on the proposed classification by examining the available evidence for all hazard classes, which were open to consultation. Concerned parties like industry are encouraged to coordinate any involvement in the RAC opinion-making process with their regular and sector-specific accredited stakeholder organisations who will attend the RAC meetings and may bring in experts on the specific topic.
  • RAC’s opinion, once finalised will be sent to the EU Commission for decision. The Commission, assisted by CARACAL (the Competent Authorities for the REACH and CLP Regulations), then prepares a delegated act to include the harmonised classifications in Annex VI of the CLP (Adaptations to Technical progress). The Commission adopts the delegated act and notifies the Council and the European Parliament who after a period of objection include the substances in Part 3 of Annex VI to the CLP Regulation. Delegated Acts are published in the Official Journal after the expiry of the objection period. Industry stakeholders can attend the CARACAL discussions on the ATPs and be accompanied by experts (upon a request to Commission).
  • If a harmonised classification of the substance needs to be re-assessed, a Member State might submit a new CLH proposal with data supporting the proposal for revision of an existing Annex VI entry. If industry has data suggesting that a change in a harmonised classification is warranted, they must submit a CLH report to a Member State Competent Authority.  

Note: The CLP, currently under revision, includes a proposal to also allow Commission to launch some harmonised classification processes, e.g., in the case of a reassessment.

C&L Inventory

The notification obligation under CLP requires manufacturers and importers to submit classification and labelling information for the substances they are placing on the market to the C&L Inventory held by ECHA. This database includes classification and labelling information on notified and registered substances received from manufacturers and importers. It also includes the list of harmonised classifications (Tables 3.1 and 3.2 of Annex VI to the CLP Regulation) and the names of harmonised substances translated in all EU languages 

An important disclaimer is that ECHA does not review or verify the accuracy of the information.More information can be found here.

Poison centres

A new Annex VIII was added to the CLP Regulation in 2017, implementing harmonised information requirements for notifications under Article 45. This information is submitted to the appointed bodies in the Member State and is used for emergency health response (the Poison Centres).

Annex VIII defines a unique formula identifier (UFI), which will be required on the label of the mixture, creating an unambiguous link between a mixture placed on the market and the information made available to emergency health response.

Updates in the GHS text are adopted through amendments of the CLP published by the EU Commission (Adaptation to Technical Process or ATPs)

More information can be found here.

Note: Importers and downstream users of “industrial use only mixtures” need to be aware of the upcoming second poison centre compliance date. From 1 January 2024, all newly submitted poison centre notifications must comply with the harmonised information requirements outlined in Annex VIII to the CLP Regulation.  

 

 

Last page update: 30 October 2023