November 18, 2020
On 13th November 2020, two delegated Acts regarding Annex VIII to CLP, on the harmonisation of information that will be made available to EU poison centres, were published in the Official Journal. The Regulations entered into force on the day they were published since the compliance date for mixtures for consumer and professional use is approaching (1st January 2021).
The first regulation is a second amendment to Annex VIII to CLP which addresses concerns raised regarding workability; the second regulation adds a new paragraph to Article 25 of CLP to address the labelling of bespoke paints.
Act Amending Annex VIII to CLP
Given the number of changes to Annex VIII, Commission Delegated Regulation (EU) 2020/1677 replaces the whole Annex for the sake of legal clarity.
The amendment mainly addresses the key workability concerns that were raised by industry, specifically dealing with:
- Different but toxicologically similar components
- Raw materials which have a highly variable or unknown composition
- Complex supply chains
- The placing on the market of bespoke mixtures
To address these highlighted difficulties, a number of new approaches have been brought in, including an Interchangeable Component Group (ICG), which provides a general solution, and a number of sector-specific solutions (for gypsum, ready mixed concrete, cement, fuels, and bespoke paints).
Interchangeable Component Group (ICG): This provides a general solution for a number of sectors to help overcome situations where different but toxicologically very similar components are used interchangeably in the formulation of mixtures. The use of an ICG is subject to meeting certain criteria.
Mixtures conforming with standard formulas: The concept of defined standard formulas for cement, gypsum binders and ready-mixed concrete has been introduced to help overcome difficulties in knowing the exact composition of mixtures at any given time, and the variations in concentration ranges exceeding those required to be declared under Annex VIII.
Fuels: For certain defined fuels it will be possible to submit the identity and concentration of the mixture’s components listed in the EU Safety Data Sheet, along with other known information on the products’ chemical composition.
Bespoke paints: Due to the very high number of possible colours and associated poison centre notifications, the proposed amendment provides suppliers of such mixtures the option to opt out of submitting information and creating a unique formula identifier (UFI) in accordance with Annex VIII.
Act Amending Article 25 of CLP
The second delegated act, Commission Delegated Regulation (EU) 2020/1676 adds an additional paragraph (8) to Article 25 of the CLP regulation, regarding the labelling of bespoke paints.
If the bespoke paint has not been notified in accordance with Annex VIII and there is not a corresponding UFI for the final mixture, the UFIs of all the mixtures contained within the bespoke paint at > 0.1%, that are required to be notified, shall be included in the supplemental information on the label, in descending order of concentration. If the concentration of any of these mixtures making up the bespoke paint exceeds 5%, the concentration of that mixture shall be included alongside the UFI on the label.
Commission Delegated Regulation (EU) 2020/1677: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1677&rid=1
Commission Regulation (EU) 2020/1676: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1676&rid=1