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Proposed Second amendment of Annex VIII to CLP to Address Workability Issues:

Draft Delegated Regulations Open for Feedback

Posted on: May 20, 2020

by Charlotte Blackburn, PhD

image of small bottle with poison written on the labelAnnex VIII of the CLP, on the harmonisation of information relating to emergency response, was adopted in March 2017; following this, a first amendment to the aspect of the regulation was published in January 2020 and saw the postponement of the first compliance deadline by one year.

After the adoption of Annex VIII, a number of workability issues were raised by a various major industry sectors; the outcome of a study on the claims and their impact concluded that a second amendment to the regulation was required. The Commission now proposes a second amendment to Annex VIII of CLP to address the concerns raised regarding workability, as well as the addition of a paragraph to Article 25 of CLP to address the labelling of bespoke or custom paints. Two separate delegated Acts have been proposed, and consultation on these took place at the 34th meeting of the Competent Authorities for REACH and CLP held on 15 May 2020. (CARACAL).

The draft delegated regulations have been made available on the Better Regulation portal and are open for feedback until 9th June 2020.

Draft delegated regulation amending Annex VIII:

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12384-Amending-requirements-for-information-for-poison-centers-

Draft delegated regulation amending Article 25 of CLP:

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12315-Amending-Regulation-EC-No-1272-2008-as-regards-supplemental-labelling-information-for-emergency-health-response

Act amending Annex VIII of CLP

Along with a few smaller changes, the proposed Act to amend Annex VIII 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, the proposed second amendment brings in some new approaches:

Interchangeable Component Group (ICG): This will provide 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 will be 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 similar reasons as those described for the cement, gypsum and ready-mixed concrete sectors, 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: A bespoke or custom paint is a paint made for an individual consumer or professional user at the point of sale by tinting or colour mixing. 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:

In addition to the proposed Annex VIII amendment regarding bespoke paints, there is also a proposed Act to include an additional paragraph (8) in Article 25 of the CLP regulation, regarding their labelling.

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 in the bespoke paint which are required to be notified shall be included in the supplemental information on the label, listed 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.

When will these proposed changes be published?

According to the current indicative timeline, adoption by the Commission is expected in August 2020. The delegated Acts will then be put forward to the European Parliament and the Council of Ministers who will have two months to raise any objections; publication in the Official Journal is expected in early November 2020.

References:

Commission Delegated Regulation (EU) 2020/11: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.006.01.0008.01.ENG&toc=OJ:L:2020:006:TOC

Commission Regulation (EU) 2017/542: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0542&rid=1

Other Poison Centre Resources:

Poison Centres: What You Need To Know

For more information about Poison Centres, check out our dedicated Poison Centres Homepage, where you can find the latest resources, including White Papers, Webinars and FAQs to help you understand your obligations under Annex VIII. You can also learn more about our expert tools and services which can help you meet your compliance requirements.

Keywords

CLP Annex VIII ; UFI ; Poison Centre


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