Working within the framework of the BPR from an industry and consultancy perspective.
Working within the framework of the BPR from an industry and consultancy perspective.
At the recent Dublin Biocide Symposium, several presenters gave their experiences of working within the framework of the BPR from an industry and consultancy perspective.
Mike McGrath, Managing Director of Necon Technologies Ltd., Ireland finds the BPR a “torture” as it is very complex and technically dense. He explained that while manufacturers and vendors are required to comply with the BPR in order to sell biocidal products, in reality many don’t comply due to the complexity of the BPR, as well as the time and money required to put a biocidal product on the market. Mike then outlined the three main routes to becoming compliant with the BPR: become a participant of a review program, obtain a letter of access, or a supply agreement. Each of these options have their own advantages and disadvantages, being a participant in a review program can be costly, and yet allows the applicant to be involved in the process and aware of any future pitfalls.
Mr. McGrath then explained that while currently there is a low public awareness of the procedures of the BPR, as well as low levels of enforcement, there are some very good reasons to follow the legal procedures. It is likely that the enforcement of the BPR procedures will become stricter in the coming years, as well as the fact that the supplier is liable in any illegal sales. The question of the best option for each company was then tackled. The approach should depend on the needs of the company, the target market, whether the company is a manufacturer or a supplier, the value of the market, and various other factors.
Mike concluded the presentation by stressing that the benefits of the BPR are not short term, but that it is there for a very good reason. It protects the environment and the consumer and allows biocidal products to be used in a safe manner.
Jose Antonio Fernandez, a biocide consultant based in Spain, outlined his personal experiences with the BPR and described the aspects to take into account when planning a biocidal product submission. Preliminary checks include the evaluation status of the active substance, the type of procedure required for the given registration, as well as investigating any possible issues with regards to Article 95. Then the product composition and uses should be prepared, deciding on the concentration of the active substance, the number of active substances used, as well as the presence of the substances of concern. A frequent mistake during this step is proposing too high of a concentration of the active substance. Factors such as the type of user, application rate, the mode of application and the target organisms should be considered.
The next step involves conducting a data gap analysis to identify the data that is required for a submission, taking into account factors such as product type or the active substance and checking for any studies that are lacking. Jose Antonio then summarised the process of carrying out a preliminary risk assessment. It is important to remember that if the product fails any of the preliminary risk assessment parts, it must be redefined again so that it can be shown to present only an acceptable level of risk. Once the preliminary risk fits with the intended uses, required data must be generated. The efficacy data is crucial, because if the product cannot be shown to be effective against the target organism, it must be redefined. Once this step is done, the full dossier is compiled and submitted.
Mr. Fernandez then described the preliminary risk assessment in more detail. The risk assessment required is based in the product being investigated. The assessment should follow the BPR guidance documents, exposure scenarios and other available literature. The worst-case approach should be taken. If no specific scenarios have been defined for the mode of use of your product, it is useful to discuss the risk assessment approach with the competent authority beforehand. If the risk assessment is not passing, there is the possibility of using risk mitigation measures. These can lead to limiting the product uses, but can save the product if there is no other option. Due to this, Mr. Fernandez stressed that, in his experience, it is important not to begin efficacy testing until a safe use for the product has been demonstrated.
The efficacy data was then discussed. The worst-case scenario should be tested in line with the intended uses for the product and target organisms, as well as ensuring that simulated-use and field trials are fully representative of the intended uses. It is very important to remember that any label claim must be supported by efficacy testing.
Finally, Mr Fernandez outlined that it is always useful to evaluate the time and cost required for evaluation with each member state when deciding on an evaluating member state, bearing in mind that some member states do not accept the responsibility of evaluating a biocidal product dossier due to their lack of resources. It is vital to inform the member state of the intentions to submit a dossier for evaluation prior to the actual submission, to allow the authority to prepare the necessary resources.
Jim Shine, a biocide consultant at Kerona Scientific Ltd. in Ireland shared his experiences with poison centre notifications. He explained the background and history of Annex VIII of the CLP, which harmonises the information requirements and submission format of the poison centre notifications, as well as specifying the unique formula identifier (UFI).
Any mixture that is classified as posing physical hazards or a hazard to human health, has to be notified. The deadline for notification for consumer and professional use products was the 1st of January 2021, while for industrial use products it is the 1st of January 2024. Mixtures already notified are valid until 1st of January 2025.
Jim then answered the question of “who must notify?”. Only companies within the EU have to carry out poison centre notifications. This includes importers, downstream users and, in certain cases, distributors and retailers. The duty holder may rely on another company to make the submission on their behalf.
The unique formula identifier was explained in more detail. It is a 16-character code that corresponds to a single mixture composition, but one mixture may have multiple UFIs. This allows for product, market and label based approaches for the company. Any change in the mixture composition requires a new UFI code. The UFI must also be clearly visible and legible on the label.
The dossier is prepared in IUCLID, which has the option of the guided dossier preparation. This simplifies the dossier preparation and guides the user through all the necessary steps. Information required includes pH, toxicological information, mixture composition, the UFI code and the product information including product identifiers, packaging, product use category and market placement. The dossier submission is carried out through the ECHA submission portal which generates a submission report (this is important as some member states require proof of submission).
Jim stressed that applicants should be aware that even in our current harmonised system there are still differences among member states and some countries might not be ready to accept notifications through the ECHA submission portal. The language of the notification might need to be changed, as not all states accept notifications in English. Some countries allow the mixture to be placed on the market after automated validation and others only after confirmation that the dossier has been received by the member state.
If you have any queries relating to the registration of biocides in the EU, please don’t hesitate to contact a member of the Kerona biocide team at info@kerona.ie, or telephone +353 1 8494284.
Please note the Jim will be presenting a free webinar on poison center notifications on Thursday 17th June at 10am. Please register at the following link https://bit.ly/3wjFf5X