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The European Chemicals Agency (ECHA) has started an EU-wide enforcement project (REF-11) that will run throughout 2023. It aims to check the compliance of safety data sheets (SDS) with Annex II of the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation.
SDS play a vital role in communicating hazard information throughout the supply chain. If inadequate, then important information concerning hazardous substances and mixtures will not be correctly conveyed to those handling them.
The Forum for Exchange of Information on Enforcement (Forum) reported that the issue of SDS substandard quality of information is a persistent problem. It stated that ‘up to 52% were found to be deficient in the Forum’s REF-2 project in 2013. Experience from enforcement activities in Member States confirms that the issue persists.’
Annex II of EU REACH outlines the content and format that all EU SDS authored after 1 January 2021 must follow. The main objective of the enforcement project is to ensure that companies who manufacture or place products on the EU market are complying with the new revised requirements of Annex II.
The Forum has begin inspections and will report on it in 2024. Furthermore, ECHA has published a revised compendium containing the recommended analytical methods companies should use when ensuring SDS compliance with Annex II requirements. The expanded compendium contains 400 analytical methods for checking REACH’s restricted substance list. This is done to ensure that these restricted substances, mixtures or articles are not improperly used within the EU market. You can read more about the enforcement project here.
Who does this apply to?
All companies manufacturing or placing products on the EU market must comply with new Annex II requirements. Therefore, all EU SDS authored after 1 January 2021 will need to comply with the new amendments. Deadline to update any SDS that were compiled according to the old Annex II requirements to comply with the updated requirements has now passed.
Relevant GB authorities have indicated that Great Britain (GB) will not be adopting this update for Annex II of UK REACH. Companies that are manufacturing or placing products on the GB market need to comply with the old Annex II requirements. However, the Health and Safety Executive (HSE) has indicated that it will be pragmatic in its approach and is likely to accept SDS authored according to either version. For those placing products on both markets, EU compliant SDS will be accepted as part of UK REACH.
If you are a manufacturer or importer of chemical substances in GB or EU, it is critical that you put a plan in place to ensure that your SDS are compliant according to the regulations in both places and that you maintain compliance for your products.
How can Ricardo help?
Ricardo's expert SDS authoring team, equipped with years of regulatory experience and close links with regulatory bodies such as ECHA, the HSE and EU Member State competent authorities can assist with all your SDS requirements – from compliance reviews and product classification to regional regulatory template set-up and translation services (in over 40 languages). We provide ongoing regulatory tracking via our Horizon Scanning service – helping mitigate risks in an ever-changing regulatory arena.
If you have any questions or concerns regarding these forthcoming changes, or want to understand what this could mean for your business, contact us today.
