How To Gain EU Approval And Authorization For Biocidal Products
The European Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) requires that companies wishing to place products that consist of, contain, or generate biocidal active substances on the European market be authorized before they can be made available. Authorization is granted after the substance has been evaluated and approved in a specific product type. Each biocidal product then receives market approval.
The objective of the BPR is to achieve a higher level of human health and animal health protection and limit adverse impacts on the environment.
Companies in scope – manufacturers or importers - must build an application dossier, or possess a letter of access to a dossier, or have access to relevant data for each active substance. Non-compliance results in removal from the market following a phase-out period that allows for safe disposal.
Depending on your presence in Europe, you can choose the type of authorization request that best fits your objectives.
Types Of Authorization Requests For Biocidal Products
ECHA assesses similarities in chemical composition and hazard for substances produced by a source that is not referenced, or for substances issued after changes in the manufacturing process or location. The initial risk assessment performed on the reference source serves as a starting point for the evaluation.
The competent authority of the Member State grants authorization at the national level, i.e., the state where the product will be made available. The authorization is only valid under the national terms and conditions.
This option is not ideal if you place products on several markets – though not in all the EU states. If so, requesting mutual recognition is a simpler procedure than applying in each state.
Mutual recognition (MR) prevents duplication of evaluation and redundant procedures. If a state has issued an authorization, recognition may be granted under the original terms and conditions. In other words, you apply once for national authorization and use the MR process in other Member States.
Certain biocidal products can receive market authorization at the EU level. National authorizations are not needed in this case and rights and obligations will be the same in all states. This procedure does not apply to products containing excluded substances: carcinogenic, mutagenic and toxic for reproduction, endocrine disruptors, Persistent, Bioaccumulative and Toxic Substances (PBTs), very Persistent and very Bioaccumulative substances (vPvB).
Biocidal Products having a more favorable hazard profile may obtain authorization through a simplified process. Such products may not contain any substance of concern, nor contain nanomaterials; they must be sufficiently effective, and do not require personal protective equipment for handling and use.
Per the Biocidal Products Regulation, an authorization is valid for a maximum of 10 years.
BPR Application Requirements
Applicants shall provide:
- A dossier for the active substance
- A dossier for at least one representative product that contains the substance
- A summary of the biocidal product characteristics
- Efficacy data
- Any other information deemed relevant
Applications are submitted via the Register for Biocidal Products R4BP 3.
Following ECHA’s initial checks, applications are evaluated by a competent authority that will rule in 365 days. After, there’s a further period of 270 days for peer review by the Biocidal Products Committee. Their opinion determines the final decision, provided no suitable substitution has been identified. Should that be the case, ECHA will launch a public consultation in parallel with the review.
It is the applicant’s responsibility to monitor the submission status and respond to requests. Lack of timely response may result in rejection.
Mandatory Data Sharing On Biocidal Products
The regulation states that authorization holders or applicants in possession of scientific data shall make it available for consultation and use by all. The objective of sharing data is to avoid costly research if such research has already been conducted. It would also contribute to reducing unnecessary animal testing.
Typical data to upload covers:
- the content of the active substance or substances
- physical and chemical properties
- methods for rendering the active substance or biocidal product harmless
- results of the tests on efficacy and effects on humans, animals, and the environment
- handling, transport, and use precautions
- safety data sheets
- product and packaging disposal
- spillage or leakage procedures
- first aid advice in case of injury
Applicants don’t have to provide data if using the product doesn’t lead to exposure, data has no scientific relevance, or data is impossible to generate.
BPR Compliance With Source Intelligence
Rich in experience with gathering substance data and making UICLID submissions to the SCIP Database, Source Intelligence offers a turn-key solution to manage the complex and lengthy process of approval requests for biocidal products. Our BPR solution:
- Collects supplier data
- Collects product data
- Gathers substance levels
- Centralizes documentation storage
- Identifies active substances
- Assesses supplier-related risk
- Rolls up data into an application dossier
- Automates submission to ECHA via IUCLID
As the leading solution provider for supply chain compliance, Source Intelligence’s mission is to help you simplify compliance and optimize supply chain visibility. BPR is one among nearly 100 global regulations for which we provide assistance, personalized advice, and multilingual non-stop support.
Start the simplified compliance journey and eliminate the headache of manual processes. Request a demo of our Biocidal Products Regulation Program today.