Frequently asked questions - Biocides
34 questions and answers on Biocides
- What is the risk of placing disinfectants on the market that are not authorised and that are not covered by an exemption?
- I want to place a disinfectant on the market with a concentration of alcohol or other active substance that deviates from the exemption for WHO formulation and the exemption for pharmacy products. Is this allowed?
- I want to put a disinfectant on the market that complies with the WHO formulation, but I have several other co-formulants in my product. Is this allowed?
- I want to use the exemptions to sell a disinfectant or make it available to private persons. Is this allowed?
- I manufacture a disinfectant according to the exemptions, but I am not on the Article 95 list. Should I purchase my active substance(s) from a supplier that is on this list?
- Who is covered by the term ‘professionals in the healthcare sector’?
- Is my disinfectant product a biocidal product or a veterinary/medicinal product?
- When is a product defined as a biocidal product?
- How do I obtain an authorisation for my biocidal product in more than one Member State?
- Where can I find the list of European biocidal product authorisations?
- When a product is intended for disinfection of medical instruments and falls under legislation for medical devices, should it also have an N number? Or is a CE number sufficient?
- When is a product on the market illegally or when is the use of a product illegal?
- What does professional or non-professional use mean for the authorisation of a biocide or plant protection product?
- Is there a difference between professional and private use of a biocidal product?
- What does the term 'expiration date' mean in the authorisation decision?
- When is a certificate of professional competence required?
- When is an exemption granted for a product (plant protection product or biocidal product)?
- What is a pre-submission meeting (PSM)?
- Will the fees and charges for applications be harmonised at the European level?
- What is a biocidal product?
- Are products for human hygiene biocidal products, medical devices, pharmaceuticals or cosmetics?
- Does a plant protection product or biocidal product have to be registered under REACH?
- What is the importance of a Letter of Access (LoA) when submitting data?
- Can data in the public domain be used?
- How does the Ctgb deal with data protection?
- How does the Ctgb define data in the public domain?
- How can I see whether a biocidal product is authorised?
- How do I introduce a biocide on the Dutch market?
- What products have now been authorised under the exemptions?
- What quality should the ingredients of the exempt formulations have?
- As a supplier of disinfectants, can I also potable alcohol, and do I have to pay excise tax?
- I want to buy disinfectants, but how do I know if it is a legal product?
- I work in a sector other than healthcare; which products am I permitted to use?
- Is it advisable to submit an individual exemption request as a company?