A BPR dossier is a critical requirement for both active substances and biocidal products under the Biocidal Products Regulation (BPR). These dossiers demonstrate safety, efficacy, and compliance but can be complex and costly to prepare.
Two Types of Dossiers in BPR:
1. Active Substance Dossier:
- Required to gain approval for the biocidal active substance.
- Includes comprehensive data on the substance’s identity, properties, risks, and efficacy.
2. Biocidal Product Dossier:
- Needed to authorise a biocidal product or product family.
- Contains technical and administrative details, including formulation, safety assessments, efficacy studies, and proposed labelling.
Why Accuracy Matters:
- Preparing a dossier can be very costly, with testing, assessments, and submissions.
- 100% accuracy is essential because failure to meet criteria can result in product rejection, causing delays and additional costs.
When Are Dossiers Needed?
- For active substance approval: Submit a dossier to gain approval.
- For biocidal product authorisation: Submit a product dossier within the grace period after the active substance is approved to keep your product on the market.
An LOA (Letter of Access) is a crucial document under the Biocidal Products Regulation (BPR) that allows companies to use data owned by another party to support their own regulatory submissions. It’s used for both active substances and products to streamline the authorisation process while maintaining compliance.
LOA for Active Substances:
- When submitting a dossier for a biocidal product, you must provide data on the active substance(s) used.
- If you’re not the data owner, you need an LOA from the active substance supplier.
- The LOA lets you reference the supplier’s data on safety, efficacy, and environmental impact.
- It’s often part of the Article 95 compliance requirements.
- Without an LOA or ownership of the active substance data, your submission cannot proceed.
Example:
If you’re creating a surface disinfectant using benzalkonium chloride, you would get an LOA from the active supplier to include their data in your dossier.
LOA for Products:
- An LOA can also apply to entire product formulations.
- Allows access to data and formulations without starting from scratch.
- Provided by suppliers offering pre-approved or extensively tested formulations.
- Can be cost-effective, reducing the need to generate full data.
- You still submit your own dossier, supported by the supplier’s LOA data.
Example:
A supplier of a biocidal cleaning product may provide you an LOA for their tested formulation, which you can submit under your own brand.
Benefits of an LOA:
- Cost savings by avoiding expensive data generation.
- Speeds up authorisation by using existing data.
- Simplifies market access, especially for smaller companies.
While costly and complex, dossiers are essential for compliance. Ensure thorough preparation to avoid rejections and delays. Start early and consult experts to get it right the first time!
An LOA is essential for navigating BPR compliance efficiently, providing a practical and cost-effective pathway to market.
