On 13 November 2020, the Delegated Regulation (EU) 2020/1677, amending Annex VIII of Regulation (EC) No. 1272/2008, and the Delegated Regulation (EU) 2020/1676, adding paragraph 8 to Article 25 of the CLP to adapt it to the changes in Annex VIII, were published in the Official Journal of the European Union.
Why the second amendment to Annex VIII of the CLP was published
The changes introduced by the second amendment to Annex VIII of the CLP were necessary due to concerns raised by various industry sectors about the practical application of the notification to the European Poison Centres portal. This notification becomes mandatory from 1 January 2021 for mixtures placed on the market intended for consumer use and professional use.
Among the main concerns expressed by industry were the difficulties in knowing the exact composition of a mixture placed on the market in cases where:
- raw materials with highly variable or unknown composition are used
- components with very similar toxicological profiles and from different suppliers are used on the same production line
- complex supply chains are involved
Another issue relates to customised paints, i.e., paints formulated in limited quantities for consumers or professional users at points of sale, with an almost unlimited number of different compositions, making it impossible to know in advance which ones will be placed on the market.
What the second amendment to ANNEX VIII OF THE CLP changes
Introduction of the “Interchangeable Component Group” (ICG)
It is now possible to group components of a mixture within an Interchangeable Component Group only if they have the same classification (physical and human health hazards), the same technical function, and the same toxicological properties.
Customised paints
Customised paints are exempt from the notification obligations under Annex VIII and from the obligation to create a Unique Formula Identifier (UFI). However, to enable poison centres to respond effectively to health emergencies, the individual mixtures within customised paints must still comply with all the requirements set out in the Annex. Therefore, the UFI of all individual mixtures contained in the customised paint must be listed on the label, along with the specific concentration of each mixture with a UFI present at a concentration greater than 5%.
Submission of information relating to standardised mixtures
There is now the possibility to submit information for certain standardised mixtures in the plaster, ready-mixed concrete, and cement sectors by referring to a standard composition when the full composition is not available.
When the 13 November 2020 amendment to Annex VIII of the CLP Regulation enters into force
Given the upcoming compliance date for mixtures for professional and consumer use (1 January 2021), both regulations enter into force the day after their publication in the OJEU (14 November 2020).
TEAM mastery, through the Product Safety division, is available to support companies in assessing their compliance requirements.