EU

How to Comply with New Poison Centre Notification Requirements for Hazardous Mixtures in EU

Little Pro on 2019-03-14 Views:  Update:2019-05-19

If you place certain hazardous mixtures on the EU market (i.e. that are classified as hazardous on the basis of their health or physical effects), you will need to update your product labels and include unique formula identifier (UFI) on them. You will also need notify those hazardous mixtures to the appointed bodies (i.e, poison centres) using the format and content harmonized by the amended Annex VIII of CLP regulation.  In this article, we will summarize how to comply with the new poison centre notification requirements in EU. 

Background

For many years, some Member States already had required companies to submit information about dangerous mixtures placed on the market and have established bodies, called poison centres, to provide health emergency response. However, this has created challenges for companies placing mixtures on the market in different Member States because they need to submit similar information multiple times and in different formats.

To solve this issue, Commission Regulation (EU) 2017/542 was adopted to amend CLP regulation. The new Annex VIII of CLP regulation sets provisions to harmonise, in terms of format and content, the information required for poison centre notifications. 

Who Shall Submit PCN

Importers and downstream users placing hazardous mixtures (that are classified as hazardous on the basis of their health or physical effects) on the EU market have direct responsibility to submit Poison centre notifications (PCN). For example, if a German importer imports a hazardous mixture and plans to supply it to multiple EU countries (France, Italy), the importer will have to submit their product information to all the appointed bodies (i.e, poison centres) of the relevant EU countries (Germany, France and Italy) before placing the mixtures on the market in those countries.

Important notes:

  • Appointed body may be a Member State Competent Authority on CLP (MSCA), a poison centre, a National Health Authority or other organizations. 
  • A formulator based in EU is generally regarded as a downstream user.
  • An export-only product does not require notification
  • Distributors who distribute hazardous mixtures only in the same MS as the supplier do not need to submit notifications. 

Mixtures Exempt from PCN

The following mixtures are exempt from the submission of PCN under CLP regulation.

  • radio-active substances and mixtures
  • mixtures for R&D use
  • waste
  • certain mixtures in finished state intended for final user: medicinal products, cosmetics, medical devices, food, etc.

In addition, mixtures only classified with gases under pressure or/and explosives under CLP regulation are exempt from PCN.

For hazardous mixtures which are not subject to submission obligations (i.e, mixtures with environmental hazards only), submission may be done on a voluntary basis.

When to Submit PCN

Importers and downstream users placing hazardous mixtures on the market not notified already under national legislation must comply with the new PCN requirements from the following dates:

  • Mixture for consumer use: 1 Jan 2020
  • Mixture for professional use: 1 Jan 2021
  • Mixture for industrial use: 1 Jan 2024

By 1 January 2025,  a submission must be made for all mixtures on the market according to the harmonised Annex VIII requirements in CLP regulation.

Information Required

The following information needs to be submitted.

  • Identification of mixture and submitter. For mixture,  unique formula identifier (UFI) , product category and product name must be provided.
  • Hazard identification and additional information. This includes hazard classification, label elements, available toxicological information, physical state and size etc.
  • Information on mixture components. Ideally, the full composition of the mixture should be indicated. Nevertheless, components do not legally need to be indicated when present in the mixture below certain concentration thresholds. Furthermore,if a mixture is for industrial use only, a limited submission is made. The information on composition may be limited to the information available in SDSs. For hazardous components which must be listed, identity and exact concentration or concentration range must be provided. 

 More info about UFI can be found below.

Unique Formula Identifier (UFI)

Unique formula identifier (UFI) is a unique 16-character code to be applied to mixture labels from 2020. By 2025, the UFI will be mandatory on the label of all preparations classified classified with health or physical hazards. Importers and downstream users placing such products on the EU market, will have to provide the UFI when submitting PCNs. One example can be found below.

UFI: E300-30P1-S00Y-5049

The UFI establishes an unambiguous link between the information you provide with the product you place on the market. All products for which submission is made with the same UFI need to share the same composition.

A software application (called the UFI generator) has been developed to help industry to generate UFIs. You need to provide company VAT number and formulation number when using UFI generator. 

How to Submit PCN

ECHA has launched a Poison Centres notification (PCN) portal to help industry both prepare and submit information on hazardous mixtures to the appointed bodies of each Member State (MS). The PCN notification can also be prepared off-line with XML tool or IUCLID and then submitted via the portal. 

The portal is free. However, a fee may be levied in each Member State for each submission. It is at the discretion of the competent authority of the Member State where the submission is to be made to decide whether fees are applicable

Reference

Having Questions?

We do not provide consultancy services. If you have questions or need any help, please contact our sponsor. You may also find an expert in CSP business directory below. If you are a consultant, you may get yourself listed in CSP business directory (free) or sponsor this page to leave your contact info on this page..

 Tags: Topics - EUGHS SDS and Labelling

Hot Articles