September 1, 2020
If you are an EU-based company importing hazardous mixtures in scope of Annex VIII into the EU, you are responsible for preparing and submitting the poison centre notification (PCN) to the relevant Member State appointed bodies. For example, if you import a mixture into Germany for your own use, you will have to notify the mixture to the appointed body in Germany since import is placing on the market; if you subsequently also place the same mixture on the market in France and Poland, you will additionally have to notify the appointed bodies in France and Poland.
If you are a non-EU supplier, you do not have a legal obligation to submit any PCNs to EU Member States. However, your EU-based customers will require information from you in order to be able to comply as importers of hazardous mixtures.
What information will importers need from their non-EU suppliers?
Ideally, a non-EU supplier will provide the EU importer with the full formulation, which will enable the duty holder to fulfil their legal obligation and submit the PCN. However, due to confidentiality reasons this may not be possible.
An alternative solution is provided in the ECHA Guidance. If the non-EU supplier has a legal entity based in the EU (or a contractual agreement with an EU-based legal entity), that EU entity can generate a UFI for the mixture and perform a voluntary PCN submission (in all relevant Member States). The non-EU supplier should inform the EU importer of the UFI and confirm a submission has been done. The EU importer can then make their own submission, referencing the UFI of their non-EU supplier’s mixture as part of the composition. The EU importer and the non-EU supplier are strongly recommended to enter into a contractual agreement to cover the details of the submission approach. Adoption of this process means that poison centres will have access to the full formulation for emergency response purposes and the original supplier of the mixture is able to retain confidential business information (CBI).
As a minimum, the EU importer should have the information for the mixture in the REACH-compliant safety data sheet (SDS). However, using only the compositional information from the SDS for the mixture would be considered a last resort; for emergency response purposes, duty holders shall make additional effort to get as much information from their non-EU suppliers as possible and are recommended to document their efforts as justification for enforcement purposes.
Poison Centres: What You Need To Know
For more information about Poison Centres, check out our dedicated Poison Centres Homepage, where you can find the latest resources, including White Papers, FAQs and Expert Articles to help you understand your obligations under Annex VIII. You can also learn more about our expert tools and services to help you meet your compliance requirements.