Europe: Annex VIII, more details from the provisional texts of the 2nd amendment

Annex VIII: what does that entail?

According to article 45 of CLP Regulation, importers and downstream users who place hazardous mixtures in the market should submit relevant information in the event of emergency health response to designated appointed bodies.

Annex VIII of CLP, added by 2017/542 Regulation, has the aim to harmonize, in terms of format and content, the information relating to emergency health responses in the EU market.

What does it mean for the chemical producer?

Among the most important innovations introduced by Annex VIII is the UFI code, a new labelling requirement for hazardous mixtures. The UFI is introduced in order to uniquely correlate the mixture placed on the market with the information contained in the declaration sent to the Poison Centres.

This 16-digit code shall be printed on the label of mixtures and will be mandatory after the related compliance date (January 1^st 2021 or January 1^st 2024), depending on the end use type of the product placed on the market. See the infographic below for more details:

As a consequence, companies that place on the European market hazardous mixtures are obliged to gather the necessary information regarding their products and to manage their product portfolio and the associated UFI codes. Click here for more on UFI code.

However, some workability studies exposed certain issues regarding elements of the information to be provided with this European notification. Although the Annex VIII text has been already updated by the publication of Regulation 2020/11 last January 10^th, the European Commission announced the entry into force of the 2nd amendment of Annex VIII around November 2020, following a scrutiny period of two months by the European Parliament. Last September 2^nd, ECHA published the provisional texts related to the 2nd amendment, containing more information regarding paints sold at POS, standard formulas and interchangeable components.

More clarifications regarding the proposed solutions

Here are the major modifications as reported in the provisional text of the 2nd amendment:

• Some products benefit from an exemption of normal compositional notification criteria, such as fuels (for which is it possible to notify the compositional information as it is printed in the SDS) or product belonging to the cement sector (for which the Regulation reports apposite standard formulas)
• Notifiers may include information regarding a group of raw materials coming from different suppliers, as long as those raw materials are toxicologically and technologically similar
• Paints made at the Point of Sales (POS) will be exempt from Article 45. However, the hazardous mixtures components of these products will still be subject to the notification obligation.

Which are the next steps?

The next step is the end of the objection period, expected on October 31^st, with the subsequent publication of the Regulation in the European Journal. Trace One is paying close attention to the evolution of the regulatory situation and will keep you updated on any news in this regard.

For more information regarding the Trace One solution for the notification in accordance with Annex VIII, please contact our Customer Service at EU-customer-service@selerant.com or click on the following link for a brief overview of the features of the UFI management and PCN dossier generation module.