Upcoming deadlines for EU BPR product authorisation based on salicylic acid, certain food contact disinfectants and insecticides
Europe: Some active substances are due for approval in 2020 under the EU Biocidal Product Regulation No. 528/2012 (BPR). The approval dates also correspond with the deadline for submitting authorisation applications for existing biocidal products containing these active substances. Companies placing biocidal products on the market that contain silver, ADBAC/BKC, DDAC, salicylic acid, acetamiprid, cyphenothrin, cypermethrin or chlorfenapyr, need to start taking action now in order to continue marketing these products in the EU after the deadline.
What is the EU BPR?
The EU Biocidal Product Regulation No 528/2012 concerns the placing on the market and use of biocidal products in the European Union (EU). Biocidal products must have demonstrated effectiveness against target organisms. The regulation also aims to ensure a high level of protection for humans and the environment.
The regulation is a two-phase approach. Firstly the active substance itself is assessed as part of an ongoing review programme. Following approval by the European Commission, the second phase is assessment of the biocidal products containing the active substance for authorisation at National or EU level.
Biocidal active substances are separated into 22 product types including: disinfectants, preservatives and pest control products.
The review programme is well underway and aims to complete in 2024. The Biocidal Products Committee (BPC) meets several times per year to evaluate and give opinions on active substance approval to present to the Commission.
Upcoming approval deadlines
The approval date of the active substance also corresponds with the deadline for submitting authorisation applications for existing biocidal products. Substances that are due for approval in 2020 and early 2021 include:
- Silver [Dec 2020] (sodium hydrogen zirconium phosphate, copper zeolite, zeolite, zinc zeolite) – food contact disinfectant and material preservative/odour control
- ADBAC/BKC and DDAC [Dec 2020] – food contact disinfectant and veterinary hygiene
- Salicylic acid [March 2020] – disinfectant
- Acetamiprid [Feb 2020], cyphenothrin [Feb 2020], cypermethrin [June 2020], chlorfenapyr [March 2021] – insecticides
Although the deadlines may seem a long way away, companies are advised to start their application process early.
Compiling the application itself can take a few months. However strategic decisions, such as choosing the biocidal products to defend and the Member States in which to sell, as well as preparing the data required for the dossier can take over a year. Generally, new studies will be required as data generated for US EPA – for example efficacy data – is not always compliant with EU requirements.
Whilst US EPA grants treated article exemptions for the non-public-health use of biocides intended to protect only the treated article or substance itself, the rules differ for treated articles under the BPR.
Articles that have been treated with or incorporate a biocidal product do not need authorisation unless they are considered as a biocidal product; however treated articles can only be placed on the EU market if the active substance has been approved or is in the review programme for that specific use. These obligations apply to both manufacturers and importers of treated articles. Furthermore, importers and manufacturers must apply specific labelling of treated articles when claims such as control of bacteria are made.
How can TSG Consulting help?
Our team of consultants have many years of experience assisting clients in navigating the Biocidal Product Regulation from active substance applications to gaining product registrations throughout the EU for a wide range of products and use areas. We are very familiar with the requirements for insecticide, repellent, disinfectant or preservative applications both for active substances and biocidal products.
We can help you with:
- Assessing your existing portfolio
- Providing strategic advice
- Biocidal product dossier preparation and submission
- Commissioning and monitoring of studies
- Guidance on label claims and data packages
Download our Biocide Regulatory Affairs leaflet now to find out more about our services.
Start planning now
If you’d like to speak with one of our experts about the planning process for dossier submissions and the steps you need to take, please complete and submit the form opposite.