Regulatory Updates: First Amendment to CLP Annex VIII

be informed

ECHA held a webinar on 12th February covering topics surrounding creating notifications to the poison centres in accordance with CLP Art. 45, Annex VIII. The webinar consisted of two parts – regulatory updates and IT tools and guidance. In this blog post, we will focus on regulatory updates as per the first amendment of Annex VIII to CLP. The first amendment, published on 10th January 2020, has been in force since 30 January 2020. The second blog post focuses on changes we can expect in the second amendment.

Change of Compliance Date for Consumer Use

The compliance date for mixtures for consumer use is now 1 January 2021. This coincides with the compliance date for mixtures for professional use. The compliance date for industrial use remains on 1 January 2024.

The move of this compliance date certainly benefits all parties affected. The industry has more time to prepare and EU Member States to develop IT systems.

Tip: Take Advantage of Transition Period for Existing Mixtures

Companies should remember that if a mixture that exists on the market is already notified to the national appointed bodies, they can benefit from the transition period until 1 January 2025. This means that until the compliance dates, companies should continue to submit notifications as how they’re already doing.

From the compliance date onwards – new mixtures placed on the market must comply with the new requirements. Additionally, any changes made to mixtures that are already notified must also comply with the new requirements.

Note that Germany and Estonia are already accepting notifications submitted in the new format via the ECHA Submission Portal.

First Amendment Editorial Clarifications

The first amendment also addressed various editorial unclarity surrounding various topics. Here’s a snapshot of the topics that were brought up during the webinar:

Positioning of UFI

The 16-digit unique formula identifier (UFI) can now be printed or affixed on the label or on the inner packaging of mixtures. This means that UFI needs to always be in proximity of other label elements, but not necessarily be a part of the label. The UFI is also not required to be placed on every layer of packaging. If due to size or shape reasons, the UFI can also only go on the outer layer only.

For mixtures for industrial use, the UFI may be listed on Section 1.1 of the SDS.

Submitter and Contact Point

Besides details of the submitter, details of the contact point is to be provided as well, where relevant. The contact point being the contact for authorities in case more information is needed. This solves the issue for example for toll formulators or where notifications are submitted centrally by the mother company.

Identification of Mixture-in-Mixture (MiM)

Where MiMs are used in a mixture, you only need to either provide the UFI that you received from your supplier or provide the known components as stated on the supplier SDS and supplier details. Do note that the UFI you received from the supplier can only be submitted if the UFI has been notified in the Member State where your mixture will be placed.

Do refer to the first amendment for details on other topics not listed here, such as pH, group submission and generic product identifiers (GPI).

You can also read about changes we can expect in the second amendment in this blog post.

Useful Links

  • Slide deck from the ECHA Webinar on 12th February, see here.
  • Guidance on CLP, see here.

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