CLP REGULATION

CLP Regulation

Regulation

Regulation (EC) No 1272/2008 (CLP) is legally binding across the Member States and directly applicable to all industrial sectors. It requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market. The classification and labelling of hazardous chemicals are based on the GHS system and ensures harmonization and adequate risk management throughout the EU.

CLP Regulation also includes the notification obligation, i.e. 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.

REACH Monitor offers the following services:

  • Compilation and evaluation of available toxicological data.
  • Assessment of the toxicological profile of substances and mixtures.
  • Classification and labelling of substances and mixtures.
  • Assistance during the CLH (harmonized classification and labelling) evaluations.
  • Assessment of the best strategy to defend substances during the CLH evaluations.
  • Intelligent Testing Strategies (ITS) to assess the classification of substances and mixtures.
  • C&L Notification of substances to ECHA.
  • Requests for an alternative chemical name in mixtures.
  • Consultancy services related to any regulatory issue.
  • Auditing services.
  • Training services.
Compilation and evaluation

Notification to Poison centres

According to article 45 of CLP regulation, certain hazardous mixtures should be notified to the Poison Centres of the Member States where the mixtures are marketed. Annex VIII of CLP regulation establishes the information requirements to be used for emergency health response.

REACH Monitor offers the following services:

      • Assessment of the client’s portfolio to identify the legal obligations
      • Compilation, evaluation and selection of the data to be notified to each Member State.
      • Notification to the different European Poison Centres according to their own national submission systems.
      • CLP Notification according to the Poison Centres Notification (PCN) format through the ECHA submission portal.
      • Updating the CLP Notifications.
      • Consultancy services related to any regulatory issue.
      • Auditing services.
      • Training services. 
Safety Data Sheets Authoring

Safety Data Sheets Authoring (SDS)

The SDS must be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market and should be kept updated.

REACH Monitor developed and maintains its own software to prepare and translate the SDSs. This system allows our team to control the origin and the quality of the information. Furthermore, the classification and labelling are always checked manually.

REACH Monitor offers the following services:

  • Compilation, evaluation and selection of the data to be included in SDS (including bibliographic research)
  • Preparation of SDS for substances and mixtures.
  • Translation of SDS into the European languages.
  • Updating the SDS.
  • Compliance check of compiled SDS according to the current standards.
  • Drawing on, checking the adequacy of, and adding to, the SDS provided by suppliers.
  • Consultancy services related to any regulatory issue.
  • Auditing services.
  • Training services.

We also offer to check the adequacy of the SDS, not only those which have been compiled by our client but also those provided by their suppliers.

REACH Monitor was certified as an SDS verification company by FEIQUE (the Business Federation of the Spanish Chemical Industry) to take part of FEIQUE’s SDS verification project.

Exposure scenarios (ES) – Annex I to the extended Safety Data Sheet (eSDS)

All registered substances under Regulation (EC) No 1907/2006 (REACH), which required the preparation of a Chemical Safety Report (CSR), should include the corresponding Exposure scenarios in the SDS to be placed in the market as a substance or in a mixture. This information should be added as Annex I of the SDS, covering identified uses and including specific management conditions.

When downstream users receive ES, they must check that they cover their own use and their conditions of use. Otherwise, they might be responsible for developing their own exposure scenario.

REACH Monitor offers the following services:

  • Evaluation of the available data in the CSR.
  • Preparation of ES for substances and mixtures
    • Compilation of ES resulting from the CSR
    • Compilation of ES from the providers’ SDS
    • Preparation of ES calculations for the own use link risk assessment
  • Translation of ES into the European languages.
  • Compliance check of ES according to the current standards.
  • Check whether the uses are covered by the ES provided by suppliers.
  • Check whether the conditions in the ES match your on-site conditions.
  • Consultancy services related to any regulatory issue.
  • Auditing services.
  • Training services.

REACH Monitor has also developed its own software to prepare and translate the ES based on the ESCom catalogue of standard phrases.

Exposure scenarios