Annex VIII of CLP (Regulation (EC) No 1272/2008 on the classification, labeling and packaging of substances and mixtures) on the harmonization of information relating to emergency response, was adopted in March 2017 in an effort to harmonize the information requirements under article 45 of CLP. According to Article 45 of CLP, member states are required to appoint a body responsible for receiving information, including chemical composition, relating to preparations placed on the market and considered dangerous. This information is to be used to meet any medical demand by formulating preventative and curative measures, especially in emergencies.

The first amendment to Annex VIII of CLP came into force on 30 January 2020. This amendment delayed the notification deadline for hazardous mixtures for consumer use by one year to 1 January 2021 and included some additional clarifications to streamline interpretation and improve coherence.

On 12 May 2020, the European Commission proposed a second amendment to Annex VIII of CLP Regulation to address several workability issues that were raised by industry and member states, specifically:

  • Raw materials with highly variable or unknown compositions
  • Different but toxicologically similar ingredients that are used interchangeably in formulations
  • Complex supply chains
  • Placing bespoke paint mixtures on the market

The proposed amendments include new approaches to deal with the issues highlighted above. The full text can be read here and is open for comments until 11 July 2020.

Additionally, the European Chemicals Agency (ECHA) recently published version 3.0 of the Guidance on harmonised information relating to emergency health response – Annex VIII to CLP. The document, which can be found here, has been updated with the first set of amendments to Annex VIII of CLP.

Amendment to Article 25 of CLP as regards bespoke paints

The European Commission has also proposed an amendment to Article 25 of CLP, regarding the labelling of bespoke paints. If a bespoke paint has not been notified in accordance with Annex VIII and the mixture does not have a UFI assigned, then the UFIs of all the notified mixtures contained in the bespoke paint must be included on the label, listed in descending order by concentration. If the concentration of any of these mixtures exceeds 5%, the concentration must be included on the label along with the UFI. The draft amendment can be found here and is open for comments until 11 July 2020.

For assistance with European poison centre notification, Contact Nexreg today!

 

Source Links:

https://ec.europa.eu/growth/tools-databases/tbt/en/search/?tbtaction=search.detail&Country_id=EU&num=719&dspLang=EN&basdatedeb=&basdatefin=&baspays=HUN&basnotifnum=30&basnotifnum2=&bastypepays=&baskeywords=&CFID=84344&CFTOKEN=967154f434fd8861-EE66649E-AF89-F78B-6B82093D33C62059

https://echa.europa.eu/documents/10162/13643/guidance_on_annex_viii_to_clp_en.pdf/412c5874-f8ec-cf52-fe1e-2fbe08fe2d11

https://ec.europa.eu/growth/tools-databases/tbt/en/search/?tbtaction=search.detail&Country_id=EU&num=720&dspLang=EN&basdatedeb=&basdatefin=&baspays=HUN&basnotifnum=30&basnotifnum2=&bastypepays=&baskeywords=&CFID=84344&CFTOKEN=967154f434fd8861-EE66649E-AF89-F78B-6B82093D33C62059