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Product Safety

New notification of Hazardous Mixtures: a summary with some suggestions

With this article we would like to share the innovations born with the Regulation (UE) 2017/542, a.k.a. Annex VIII of the CLP.

Regulation (EU) 2017/542, a.k.a. Annex VIII of the CLP, is about the new notification method of hazardous mixtures.

CLP Annex VIII introduces many changes for companies that place hazardous mixtures on the European market on the basis of their health and physical effects.

In this article we would like to summarise the major changes brought by this new Annex. For that reason, we have prepared the following table to describe some actions that companies should consider in order to comply timely with their new obligations. 

Regulatory duty Actions

Application
All mixtures placed on the market and classified as hazardous on the basis of their health and physical effects in accordance with Art.45 of CLP Regulation.

Companies shall identify the hazardous mixtures classified on the basis of their health and physical effects.

Deadlines
Notifiers shall comply to the new notification system according to the following deadlines:

  • from 1 January 2020: mixtures for consumer use
  • from 1 January 2021: mixtures for professional use
  • from 1 January 2024: mixtures for industrial use

Companies shall identify their notification deadlines according to the end use of the mixtures placed on the market.

Transitional period
Notifiers having submitted information in accordance with Article 45 shall comply from 1 January 2025, if the mixture is not subject to changes in the meantime.

Companies shall verify the correct notification status of the mixtures.

Timing
Submitters shall provide information relating to mixtures before placing them on the market.

Companies shall plan notifications before placing mixtures on the market 

The UFI code (Unique Formula Identifier)
UFI is an alphanumeric code linked to the composition of the mixture. The submitter shall create it prior to the submission. The UFI code shall be affixed on the label alongside the other label elements in accordance with CLP Regulation.
Furthermore, the UFI code shall be indicated in section 2.2 of the safety data sheet (SDS).

Creation of UFI codes and review of SDS and labels contents. 

Product category
Describes the identified use of the mixtures placed on the market through a harmonised system, the EuPCS (European product categorisation system). 

Companies shall assign a product category to each mixture.

Information about the composition and MIMs (mixtures in mixtures)
Submitters shall provide information about components of the mixture, independently of their classification as hazardous or non-hazardous.

Companies must be in possess of Detailed information about the composition of the mixtures; if mixtures are formulated using other mixtures, notifiers will need to contact all their suppliers to obtain the information.

Toxicological information
Submitters shall provide detailed toxicological information relating to mixtures.

Notifiers need to obtain detailed toxicological information in order to provide all the information relevant to an emergency health response.

The notification shall be provided through a harmonised format, the Poison Centre Notification (PCN format). Furthermore ECHA is developing the “PCN portal” which is a submission system that could be used to submit the notifications at the discretion of each MS.

Conclusions.

Reg. UE 2017/542 introduces new relevant duties for chemical companies.

The deadlines by which the obligations have to be fulfilled are not so far in the future: it would be appropriate for companies to start planning proper actions concerning this topic.

The work will require many activities:

  • creation of UFI codes;
  • assignment of PRODUCT CATEGORIES;
  • re-labelling of products already placed on the market;
  • revision of the safety data sheets for chemical products.

Clearly, doing this kind of activity in a very short period of time will require a lot of energy. Furthermore, these activities will require a lot of time, a lot of technology and new skills.

To clarify possible doubts or difficulties that companies of chemical products can meet in complying with these legal obligations, SELERANT and NORMACHEM have provided two ad hoc webinars.

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