Your Questions Answered | Chemical Regulation Webinar – June 2024 | Insights

Recently, our experienced team of chemical regulatory experts hosted a webinar looking at the upcoming changes to UK and EU legislation and the likely impacts these will have on the chemical sector and those who use its products. The level of engagement on the day was overwhelming, with many questions left unanswered due to the limited time available. Here, our experts have gathered the answers and provided more information on the most common topics and key questions.

Aiming to cover the key factors impacting regulatory compliance for chemical companies and their value chains, by explaining the latest regulatory developments and discussing expected changes on the horizon, we hope you found the session informative and valuable.

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Answers for your questions

1. Which countries have additional reporting requirements beyond the responsibilities of the local poison control center?

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

2. Which countries still have local systems in place alongside the ECHA portal?

Countries such as Bulgaria, the United Kingdom, Northern Ireland and Switzerland continue to operate local systems, whilst other countries have requirements relating to annual tonnage reporting and use of Poison Centre telephone numbers which require additional pre-market action, including: Austria, Belgium, Croatia, Italy, Hungary, Ireland, Latvia, Norway, Sweden, Finland and Denmark.

3. CLP labelling requirements – does the EU address have to be a staffed EU address or is a PO box acceptable?

Regulators expect someone to be available to answer questions/take responsibility for the product (and be held accountable if it all goes horribly wrong!) A PO box/brass plate address is generally not considered acceptable.

4. Do you think the HSE will accept the reclassification of SDSs and labels in line with EU and GB regulations?

If a substance has a mandatory classification, companies will not be able to overclassify it in the same class. Article 15(1) GB CLP Regulation 4 states that “Manufacturers, importers and downstream users should adapt the classification of the substance or mixture in accordance with the results of the new assessment, EXCEPT where there are mandatory classes or distinctions for substances included in the UK Mandatory Classification and Labeling Inventory.”

But companies have been doing this for a long time – for example, when the Risk Assessment Committee (RAC) published an opinion that changed the harmonised classification, but they did not want to wait until it was adopted in Annex VI to implement it. As far as we know, no one has ever been accused of adopting a stricter classification with evidence to support it.

5. Is the poison centre notification for Switzerland different from the notification for the EU, which will require full disclosure of the formula, including the full composition of the fragrance oil?

Yes, the process is different because Switzerland is not part of the ECHA portal. Switzerland runs its own portal which requires similar data and requires the full preparation to be sent.

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

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

7. Following the Poisons Centre notification, can we expect the UK to have a specific platform for PCNs post-Brexit?

The HSE is currently testing the portal, however there is currently no confirmation regarding a specific poison center notification platform.

8. Is it possible to submit a notification to the poison control center in the case of many similar preparations?

There are solutions to test the feasibility of similar formulations, but strict rules apply.

9. Where can I find the ATP22 and ARTP23 test design?

22. The ATP was developed and notified to the WTO in January 2024. Draft ATP documents can also be viewed on the CARACAL Public Interest Group.

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

Yes, the HSE is issuing new REACH registration numbers in the UK. The format is the same as the EU registration numbers but with the letters “UK” added to the front.

11. Is ATRm available to read somewhere?

The ATRm consultation is available on the Defra website. Read our expert review of the consultation here.

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

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

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

These have been included in the upcoming revision of the CLP, the draft adopted text is available here.

14. How should labels be managed for import and export?

Legal responsibility for compliance with CLP lies with the EU importer when importing into the EU and with the UK importer when importing into the UK. Non-EU/UK companies can assist their customers by preparing and applying product labels to EU/UK specifications when supplying products to them. The legal requirements for exports are covered by the Prior Informed Consent (PIC) Regulations, Art. 17, which require that, as a minimum standard, exported chemicals must be labeled in accordance with CLP, unless this would be contrary to the national requirements of the importing country.

15. Is a current safety data sheet required for samples sent within the last 12 months?

If a safety data sheet has been required by law and there is new information that can be updated, an updated safety data sheet must be provided. For more information, please contact Ricardo.

16. What does ATRM mean for NRES? Do I need to upload a full data package to enter the market?

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

17. In the context of the timeline, would you recommend requiring new SDSs for existing formulations and changing the information on packaging after 1 September 2025 to reflect ATP21 to avoid deletion and removal of packaging that will soon become non-compliant?

The last date for submitting applications under the 21st ATP is September 1, 225. This means that all safety data sheets and labels must comply with its requirements by this date. You must report any changes to CLP yourself. Waiting until the deadline for suppliers to update would not be a reasonable justification for non-compliance.

18. Resolution of discrepancies in Annex VI and GB MCL: 1) Will over-classification be a legal way to maintain the same label in cases where Annex VI is more stringent than GB MCL? 2) Some of these discrepancies seem to me to be obvious cases of human error in rushed work. Nevertheless, they are the law. Do you want a chance to fix this in the future?

Mandatory classifications may be reviewed when new data becomes available indicating the need to update the classifications. The industry may initiate new and updated classifications, but fees may be required.

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 can I find UK REACH and CLP regulations? Is there a consolidated document?

Consolidated documents are 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 changes to booklet/peel-and-read labels allow for more uniform labelling without the need for country-specific language on the labels for each EU territory?

Label information will continue to be required in all languages of the Member States where the product is placed on the market. In the future, some additional label information may only be provided in digital form.

22. Regarding SDS handling and labelling for Northern Ireland, we know that Northern Ireland requires a PCN notification with the appropriate UFI code, but requires clarity on SDS (format and classification), CLP labelling and possible environmental labelling requirements (recycling…). Do they need to comply with UK regulations or do they need to comply with EU regulations like Ireland? If we need to provide dual labelling/classification for Republic of Ireland and another for the UK, how should we treat Northern Ireland in terms of labelling, classification and SDS?

When it comes to recycling labelling, Northern Ireland falls under the UK system, where a recycling label on packaging is currently voluntary, but from April 2027 it will be mandatory for all packaging to be labelled with a binary ‘Recycle or Don’t Recycle’ label. Businesses selling to other countries can add the words ‘UK Only’ above the recycling label to make it clear to consumers which disposal system they are referring to. The Republic of Ireland has its own packaging labelling scheme, run by My Waste – there are currently no plans to make this voluntary scheme a mandatory requirement.

Support for your organization

Our dedicated and experienced team of subject matter experts can support your organisation by providing informed guidance and advance notification of upcoming changes. Having worked with chemical sector organisations since 1973, our experience allows us to translate regulatory changes into required actions and create transition plans for the industry-leading organisations we work with. Our position of expertise also allows us to offer regulatory training to internal teams to ensure subject matter certainty and organisational compliance.

Able to offer a full suite of compliance solutions, Ricardo can tailor services to suit any organisation’s needs, from Poison Centre notifications to Safety Data Sheets, REACH Only Representative services and documentation, labelling, product and organisational sustainability – our cross-disciplinary teams are here to support your organisation in meeting its current challenges whilst working towards its goals.

If you have unanswered questions or would like to discuss the regulatory and compliance challenges your organization is facing, contact our team of experts for a free, no-obligation conversation.

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