December 18, 2023
By Susana Planas MunGavin, BSc, MSc, senior regulatory specialist, UL Solutions
On Dec. 8, 2023, the Department of Health and Social Care (DHSC) laid before Parliament, the CLP (Amendment and Consequential Provision) Regulations 2023, S.I. No. 1344. They come into force immediately and make consequential amendments to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (GB CLP Regulation). The mention of Annex VIII has been removed following the revocation of Annex VIII of the GB CLP Regulation by the Retained EU Law (Revocation and Reform) Act 2023. Pursuant to Part 2 of Schedule 1 to the 2023 Act, Annex VIII of the GB CLP is revoked and is set to expire on Dec. 31, 2023 due to a “sunset” clause of the 2023 Act.
The main purposes of Annex VIII of the GB CLP Regulation was to address for each hazardous mixture placed on the market, information relating to the concentration of mixture components, relevant for formulating preventative and curative measures in the event of an emergency health response. This information was used for the purpose of toxicovigilance as foreseen by Article 45 of the CLP Regulation.
The DHSC, the UK Health Security Agency, Department for Business, Energy, and Industrial Strategy (now Department for Business and Trade), and industry at large concluded that the costs faced by industry for meeting the mandatory reporting requirement as set out in Annex VIII outweighed the public health benefits when compared to the existing voluntary reporting approach.
The removal of Annex VIII mandatory reporting requirements is ultimately intended to minimize confusion relating to the harmonized information on hazardous mixtures placed on the market that was required to be submitted to the National Poisons Information Service (NPIS) by importers. These included mainly those responsible for the physical introduction of chemicals into GB and downstream users, who are using chemicals in the course of their industrial or professional activities, excluding manufacturers and importers.
The amending statutory instrument replaces the mention of "mandatory" reporting in reference to Annex VIII throughout the GB CLP Regulation and replaces it with ‘voluntary’ reporting. It also revokes the following retained EU legislation, now redundant due to the revocation of Annex VIII of the GB CLP Regulation by the 2023 Act, including:
- Commission Regulation (EU) 2017/542 of 22 March 2017 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response;
- Commission Delegated Regulation (EU) 2020/11 of 29 October 2019 amending Regulation (EC) 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards information relating to emergency health response;
- Commission Delegated Regulation (EU) 2020/1676 of 31 August 2020 amending Article 25 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards bespoke paints; and
- Commission Delegated Regulation (EU) 2020/1677 of 31 August 2020 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures in order to improve the workability of information requirements related to emergency health response.
Recommended action items
- Review any hazardous mixtures placed on the market for which Annex VIII harmonized information had been submitted to the NPIS
- Be aware that the submittal of such information is now voluntary
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