Experiences with Harmonising Mutual Recognition Procedures
Experiences with Harmonising Mutual Recognition Procedures
During the Dublin Biocides Symposium 2024, Lucas Kalker (Senior Policy Advisor, Ctgb) gave an insightful look into the harmonisation of mutual recognition under the BPR and the trends that have appeared over recent years.
The current system allows for Member States who disagree with a decision to voice their concerns formally through a dispute committee known as the “Co–ordination committee”. Lucas discussed the importance of harmonisation and ensuring a level playing field in the EU market while also highlighting the difficulties of the current system. These difficulties included the time consuming nature of the referrals which can lead to “moving goal posts” and the increase in cost of applications which comes with additional work.
An analysis was done examining the number and complexity of referrals in recent years with a focus on numbers in the Netherlands.
“The concept of ‘mediation of disputes through referrals’ is the pinnacle of harmonisation. However, under the current workload, is it still justified to spend so much time on issues that affect only one or a few products?”
The Dutch analysis found there are 30 referrals on average per annum within the EU, with many similar applications leading to the same kind of referrals. The Dutch Policy for referrals is to refer only if a risk has not been identified within the evaluation and to check if a similar successful referral had been raised for a similar instance.
Overall, referrals are the way for harmonisation but there are still steps that Member States can take to improve the system. The reference competent authority and the applicant should identify triggers for future referrals early to allow for as much time as possible. Before initiating a referral, one should consider; does it alter the conclusion of the risk assessment; Has there been a similar case in the past?
If you missed the Biocide Symposium, a copy of all the presentations is available on the publications section of the Kerona website at the link https://kerona.ie/product-category/publications/
Please contact the Biocide regulatory consultants at Kerona info@kerona.ie if you need support with the registration of biocides in the EU and the UK.