Your questions answered: Chemical regulations in the UK and EU

Recently, our experienced team of chemical regulatory experts hosted a webinar exploring the incoming changes from UK and EU legislation and the likely impacts these would have on the chemical sector and those using its products. There was an overwhelming level of engagement on the day, and lots of questions remained unanswered due to time constraints. Here, our experts have collated responses and shared more information on the most common topics and key questions.

Aiming to consider the key factors impacting regulatory compliance for chemical companies and their value chains by providing clarification on the latest regulatory developments, and by discussing the anticipated changes on the horizon, we hope that the session was informative and valuable.

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Your questions answered

1. Which countries have additional reporting requirements beyond the local poison centre?

Bulgaria, Austria, Belgium, Croatia, Italy, Hungary, Ireland, Latvia, Norway, Sweden, Finland, Denmark, Great Britain, Northern Ireland & Switzerland

2. Which countries are still running local systems alongside the ECHA portal?

Countries such as Bulgaria, Great Britain, Northern Ireland & Switzerland continue running local systems, whilst other countries have requirements related to annual tonnage reporting and the use of the Poison Centre phone numbers, which require additional actions before placing on the market , including: Austria, Belgium, Croatia, Italy, Hungary, Ireland, Latvia, Norway, Sweden, Finland & Denmark. 

3. CLP Labelling Requirements – does the EU address have to be a manned EU address, or is a PO box acceptable?

There is an expectation from the regulators that there will be a person available who can answer questions/take responsibility for the product (and be prosecuted if it all goes horribly wrong!). A PO Box/brass plate address is generally not considered to be acceptable. 

4. Do you think the HSE will accept overclassifying on the SDS and labels to both EU & GB regulations? 

If the substance has a Mandatory Classification then companies will not be able to overclassify in the same class. Article 15(4) of the GB CLP Regulation states that “Manufacturers, importers and downstream users shall adapt the classification of the substance or the mixture in accordance with the results of the new evaluation EXCEPT where there are mandatory classes or differentiations for substances included in the UK mandatory classification and labelling list.”

However, companies have been doing this for a long time – for instance, when a Risk Assessment Committee (RAC) opinion has been published that changes the harmonised classification but they don't want to wait until it is adopted in Annex VI to implement it. To our knowledge, no-one has ever been prosecuted for adopting a more severe classification where they have evidence to support it.      

5. Is the poison centre notification for Switzerland different from the EU that will require to provide full formula disclosure including full fragrance oil composition? 

Yes, the process is different as Switzerland is not part of the ECHA portal. Switzerland run their own portal which requires a submission of similar data, and you are required to submit your full formulation.        

6. Can you add supplementary classifications to the MCL classifications? How do we keep track of substances as part of the new hazard classes?

Some substances have already been identified as meeting the criteria for the new hazard classes as part of evaluations under other legislation (REACH Candidate List of SVHC, Biocidal Product and Plant Protection Products regulations). These are expected to be transferred into the list of harmonised classifications within 18 months of the CLP revision coming into force. Companies should already have identified these as part of their obligations under these regulations, and can update their registrations, SDS, labels, etc accordingly now. For other substances, monitoring of various regulatory and screening lists can help to identify any potential concerns. 

7. With Poison Centre notification, is there any expected time where the UK will have specific platform for PCN further from Brexit?

The HSE is testing a portal currently, however there is no confirmation of a specific platform for Poison Centre Notifications currently.

8. Is it possible to submit Poison Centre Notifications for multiple similar formulations?

There are workability solutions available to support similar formulations, however there are strict rules for this. 

9. Where can be found draft test of ATP22 and ARTP23?

The 22nd ATP was drafted and notified to WTO in Jan 2024. Draft documents for ATPs can also be viewed at the CARACAL documents public interest group.

10. Will substances get a new UK REACH registration number?

Yes, the HSE are assigning new UK REACH registration numbers. The format is the same as EU registration numbers, but with the letters “UK” added at the start. 

11. Is the ATRm available somewhere to read?

The ATRm consultation is available on the Defra website. Read our expert insight on the consultation, here.

12. Where can I find the classification inventory data valid in UK ? (similar to C&L inventory)

The Mandatory Classification List (MCL) is available on the HSE website as a spreadsheet download.  

13. Where can we find information on the upcoming requirements for distributors?

These are included in the upcoming CLP Revision, the draft adopted text is available here. 

14. How are labels expected to be managed regarding imports & exports? 

Legal responsibility for compliance with CLP rests with the EU importer for imports to the EU, and with the GB importer for imports to GB. Non-EU / GB companies can assist their customers by preparing and applying product labels to EU / GB specifications when supplying products to them. Legal requirements for exports are covered by the Prior Informed Consent (PIC) Regulations, Article 17, which require that, as a minimum standard, exported chemicals be labelled with a CLP compliant label, unless that would conflict with the national requirements of the importing country. 

15. Do you have to supply updated SDS for samples sent within the last 12 months? 

If a SDS was legally required to be provided, and there is new information that would update, then an updated SDS should be supplied. Contact Ricardo for more information.

16. What does ATRM means for NRES ? Need to submit full data package to enter market?

New registrants (NRES) will have to bear data ownership costs. This may change in the future, but this is the current proposal in the Defra consultation.    

17. In terms of timing, would you recommend requesting new SDS's for existing formulations and changing on pack information after 1 September 2025 to absorb ATP21 to avoid writing off and disposing packaging that would soon be non-compliant? 

The latest application date for the 21st ATP is 1st September 225. This means that all SDS and labels must be compliant with it’s requirements by this date. You need to keep aware of any changes to CLP yourself. Waiting until after the date for suppliers to update you would not be a reasonable justification for failing to comply. 

18. Reg. the diverging Annex VI and GB MCL: 1) Will over-classification be a legal way to keep the same label in cases where Annex VI is stricter than GB MCL? 2) Some of those divergences seem to me obvious cases of human error doing a rushed job. They are the law, nonetheless. Want are the chances for this being corrected in the future?

Mandatory classifications may be reviewed when there is new data that indicates an update to the classification is needed. Industry can initiate new and updated classifications, but fees may be payable. 

19. What is expected regarding self-classification of products?

There are no changes to these requirements. Suppliers must classify, and, if necessary, label their products before placing them on the market. 

20. Where do you find UK REACH and CLP regulations? Is there a consolidated document?

There are consolidated documents available on the UK legislation website: https://www.legislation.gov.uk/eur/2006/1907/contents and https://www.legislation.gov.uk/eur/2008/1272 

21. Will the new booklet/peel and read label changes allow a more standardised label without the need to include country specific language on labels for each EU territory? 

Label information will still be required in all member state languages where the product is placed on the market. In future, some supplementary labelling information will be able to be provided digitally only. 

22. Regarding the handling of SDS and labelling for Northern Ireland, we know that Northern Ireland require PCN notification with the relevant UFI code, but require clarity over SDS (format and classification), CLP labelling and possible environmental labelling (recycling…) requirements. Do these have to be UK-compliant or do they have to follow EU regulations like Ireland? If we have to provide double labelling/classification for the Republic of Ireland and another for UK, how should we handle Northern Ireland for labelling, classification and SDS?

In terms of the recycling labelling Northern Ireland comes under the UK system, where currently On-Pack Recycling Label is voluntary but from April 2027 it will be mandatory to label all packaging with the binary "Recycle or Do not recycle" labels. For companies who sell products into other countries, they can add a "UK Only" above the recycling label to make it clear for consumers which waste system they are referring to. The Republic of Ireland have their own labelling system in place for packaging, run by My Waste – this voluntary system has no current plans to make it a mandatory requirement.

Support for your organisation

Our dedicated and experienced team of subject matter experts can support your organisation by providing informed guidance and forward notice of impending changes. Having worked with chemical sector organisations since 1973, our experience enables us to translate regulatory changes into the required actions and create transition plans for the industry leading organisations we work with. Our position of knowledge also enables us to offer regulatory training for in-house teams, to ensure subject matter confidence and organisational compliance. 

Capable of offering a full complement of compliance solutions, Ricardo can tailor services to suit the needs of any organisation, from Poison Centre Notifications to Safety Data Sheets, REACH Only Representative services and dossiers, to labelling, to product and organisational sustainability – our cross-disciplinary teams are here to support your organisation with current challenges, while progressing towards your goals and objectives.

Should you have any questions that remain unanswered, or if you wish to discuss the regulatory and compliance challenges facing your organisation, please contact our team of experts for a free, no-obligation discussion.

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