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Reporting mixtures in a PCN jacket

Since 1 January 2021, harmonised information on mixtures classified for health or for having hazardous physico-chemical properties according to Annex VIII to the CLP Regulation1 must be submitted in PCN format (Poison Centres Notification Format). This new format is already mandatory for mixtures intended for consumer or professional use, while for mixtures that are solely intended for industrial use, this obligation has been postponed till 1 January 2024. Mixtures notified to the national register of chemical substances and devices before 1 January 2021 need not be declared in the new format until 2025 provided that no basic changes in the reported mixture occur till then.

Information can be submitted in the harmonised XML format, administered by the European Chemicals Agency (ECHA). The harmonised XML file can be set up by using the current IUCLID code or its online version, IUCLID cloud. This is not the first time ECHA uses such IT tools, you may have met with them, for instance, when submitting information according to the REACH2 (registration), CLP1 (substance classification notification) and BPR3 Regulations. The new PCN format in which information should be submitted to ECHA is primarily meant to unify the required data within the EU for mixtures that are put on the market, particularly identification of the mixture and of the entity responsible for putting it on the market, its composition, use(s), product categorisation according to the EuPCS, etc. This change also entails the obligation to report the unique formula identifier – UFI code, used by European poison centres to uniquely identify the mixture.

This obligation to notify the Poison Centre (European toxicology centre) applies, in particular, to the importers and downstream users. Since the submission of information in PCN format is one of the shared obligations within the supply chain, this obligation can also be indirectly passed on to the distributor.

The change in the declaration of mixtures within the European Union has also been transposed to the Czech national legislation, specifically by amending the Chemical Act4. It is noteworthy that this change also applies to mixtures that are also covered by other legislative acts, such as the Regulation on detergents5 and Regulation on biocidal products3, and to mixtures serving plant protection purposes6  – for this reason, the Ministry of Health has issued guidelines on the declaration of hazardous mixtures in accordance with Annex VIII to the CLP Regulation1.

So, no exceptions can be used after 1 January 2025 and all mixtures that are put on the European market will have to be declared to the European Poison Centre in PCN format. The new mixture declaration is more tedious and time-consuming than the old declaration, and if you are seeking a reliable partner, contact us and we will be happy to provide this service for you. We cover the complete service portfolio and can be a reliable partner in other chemical legislation areas as well.

Authors: Ing. Aneta Nezmeškalová, Ing. Sabina Fraňková

  1. Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)
  2. Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
  3. Regulation (EC) No. 528/2012 concerning the making available on the market and use of biocidal products (BPR).
  4. Czech Act No. 350/2011 Coll., on chemical substances and chemical mixtures (Chemical Act)
  5. Regulation No. 648/2004/EC on detergents
  6. Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market