Biocide Regulation in Europe
In the EU/EEA, three separate legislations – BPR, CLP (Classification, Labelling and Packaging) and REACH – may need to be considered when seeking registration or authorization of biocide active substances and biocidal products, respectively. BPR is the main regulation, which is administered by ECHA working with individual evaluating member state competent authorities (eCAs). The first step in launching a biocide onto the European market is to have the active substance approved. After approval of the active substance, you then apply for specific biocidal product authorization via one of several possible routes.
Covance has a proven track record of supporting clients through BPR in Europe. By partnering with us, you will benefit from extensive insight and practical experience gained through both active substance approval and product authorization.
- Dedicated team of BPR specialists working within the wider team of regulatory scientists
- Comprehensive management of all the financial, legal and administrative aspects of handling a registration group
- Track record of managing active substance approvals through BPR submission – from Article 95 applications to full submissions
Navigating BPR and registration group agreements
Unlike REACH, ECHA does not mandate that companies work together to submit a single registration dossier for each biocidal active substance under BPR. However, many companies choose to do this as registration groups to help contain costs. Setting up a registration group means identifying other registrants, confirming equivalence of active substances and then negotiating to form the group or purchasing access to data through a letter of access. Navigating the legal, financial and administrative aspects of active substance approval can be time consuming and can slow your regulatory journey.
Creating an evidence base to support your substance’s efficacy and safety claims
You may have a new active substance requiring approval under BPR or an existing substance that is part of the BPR review program. Either way, you need an up-to-date dossier that captures evidence of your substance’s efficacy and demonstrates safety to human health and the environment. The dossier must meet the criteria of the BPR, which has evolved; therefore, older substances submitted under previous legislation, may lack the right data.
Managing all the financial, legal and administrative aspects of your task force agreements
A collaborative approach and positive proactive communication form the bedrock of our successful leadership of registration groups. As your partner, we can negotiate the legal and financial set up of joint agreements, protecting your goals and interests. With in-depth regulatory knowledge, plus a keen focus on all technical and administrative details of task force agreements, you can rely on us to keep things on track. Covance can also support you in drafting letters of access to our existing managed task forces so you can obtain the data you need.
Building robust and high-quality active substance dossiers aligned to all BPR requirements and eCA needs
With many years’ experience working with ECHA and different eCAs, we understand the nuances of interpretation and variations in working practices that exist across Europe. This insight enables us to optimize your active substance submissions to ensure smooth regulatory passage. Our team anticipates possible hurdles and works proactively with the regulator to address them. This keeps you on time and budget.
Covance can assemble a complete dossier for your substance. From identifying and filling data gaps with a tailored program of testing, supplied by our world-leading testing labs, through to completing an IUCLID dossier and submission via R4BP - This is an end-to-end service designed for both approval success and efficiency.
Services Covance undertake for active substances under BPR include:
- IUCLID dossier preparation for both new active substance(s) or Article 95 application(s)
- R4BP submission
- Regulatory support regarding approval of existing actives
- Tier I and II technical equivalence applications
- Transitional notifications
- EU representation for non-EU companies under Article 95
Keeping ahead of the BPR review program
Since the EU Biocidal Product Regulation 528/2012 came into effect in September 2013, ECHA has been reviewing registered active substances. The review program will continue until 2024. Our dedicated biocides regulatory team has vast experience in supporting active substances through BPR review. By levering our insight into regulatory priorities, we can anticipate likely challenges and prepare in advance. This keeps you on track to approval and helps minimize delays.