Outcome interviews

The UK HSE conducted 21 interviews with many different affected businesses to better understand the effect that Article 95(5) might have on the GB biocides market. The main themes coming out of the interviews included:

• Lapsing of data protection could lead to active substance supporters withdrawing active substances from the GB market because they will no longer be financially viable,
• Article 95(5) as it currently stands would allow alternative suppliers of active substances to access the GB market ‘free riding’ onto the GB Article 95 List (the GB list of active substance suppliers) with minimal expense, undercutting suppliers who have invested heavily in regulatory data. This was considered to be unfair,
• There were also concerns that this could allow substandard active substances, manufactured at lower costs, to enter the supply chain and be used in biocidal products, which could lead to harm to the environment and public health.

UK HSE decision

Following on from this, the UK HSE agreed to extend the end date of data protection by 5 years from 31 December 2025 to 31 December 2030. A UK Statutory Instrument (SI) – comparable to the EU Implementing Regulation for the non-UK followers- is in the making.

The intention of this statutory instrument is to prevent a hard stop on data protection at the end of the year, giving a period of certainty to industry over data protection rules in GB. This UK HSE decision will also allow the UK authorities to further consult on long-term policy options (e.g. coupling of data protection extension with extensions of the Review Programme) and taking the  progress of UK HSE’s planned wider reforms to UK chemicals regulations into consideration. 

This planned SI will also make some minor technical amendments to Article 95(5) to ensure it works as intended. It is not known yet if this would include any limitations of the protection of data that has already been submitted under the Biocidal Products Directive (i.e. studies developed well before 2012). We will follow these updates for you closely.

Please note that the formal implementation of this SI, covering the GB BPR data protection hard stop extension, remains subject to consent from the Devolved Governments and parliamentary scrutiny processes.  Once the UK HSE has communicated more widely upon certainty that this SI will go ahead, we will let you know via our LinkedIn page. Please make sure you follow this closely.

The EU to follow?

Finally, we are looking forward to a similar decision of the European Commission as also EU based biocide industry needs a long period stability to ensure that their investments in active substance approvals and product (family) authorisations remain financially viable. This will allow important biocides (for e.g. disinfection and hygiene, product preservation, pest control, marine antifouling, etc.) to remain available for both UK and EU citizens.