No, Annex I of the EU Biocides Regulation is the list of active substances that can be used in products that qualify for the simplified authorisation procedure.
It does include some of the substances that were Included into Annex IA of the BPD.
The active substances originally listed in Annex I of the BPD considered to be Approved under the EU BPR and are included in the EU BPR Union list of approved active substances (Article 9).
The European Commission has published Regulation (EU) No 736/2013, which extends the deadline for completion of the biocide active substance review programme from May 2014 to the end of 2024.
To ensure that the biocides active substance review programme is complete by the end 2024, Annex III of the Review Regulation (Regulation (EU) No. 1062/2014) of the EU Biocides Regulation establishes legally binding deadlines for competent authorities to submit their assessment reports to the European Chemicals Agency (ECHA) and deadlines for ECHA to submit their approval/non- approval opinions to the EU Commission.
The detail concerning the progress and possible outcome of a specific active substance review is confidential to the Notifier(s), the Commission, ECHA and the Competent Authority. We therefore advise that you contact the Notifier directly and ask to be updated. The EU Commission publishes the names of the participants and applicants whose dossiers are being examined under the active substance review programme.
A list of the Article 9 approved active substances can be found on the European Chemicals Agency (ECHA) website.
If you are unsure if your active substance(s) is approved or support for review for your product type, details of how to check are on our Active Substance Status page.
The date (1st September 2013) mentioned in Article 95 (1) of Regulation (EU) No 528/2012 is the date from which submission can be made - not by which the submission has to have been made.
Article 95 (2) of Regulation (EU) No 528/2012 makes it clear that after the 1st September 2015, if neither the active substance supplier or product supplier are on the list, then biocidal products can not be made available on the EU market.
The European Chemicals Agency (ECHA) has set up a process for companies to make their submissions and gain entry to the list and published guidance , describing the obligations under Article 95 and explaining the regulatory consequences.
ECHA is responsible for publishing the list of persons having submitted a dossier or a letter of access.The list is available on ECHA’s website and will be updated by them as and when necessary.
In accordance with Article 95 of the EU Biocides Regulation it is a requirement that either the active substance supplier, or if necessary the biocidal product supplier, appear on the Article 95 list. They gain entry to the list by submitting to ECHA either an active substance dossier or a letter of access to such a dossier. Those organisations that have already complied with this requirement appear in ECHA's list of active substance suppliers. If your supplier is not on the list then we suggest you contact them and enquire about their intentions with regard to Article 95. If your active substance supplier does not intend to comply with Article 95 then you may have to consider switching to an alternative source that is included on the Article 95 list, or applying for entry to the list yourself as a product supplier. Biocidal products containing active substances from suppliers that fail to be included on the Article 95 list cannot be made available on the EU market as of 1 September 2015.
In order to increase transparency for the biocides industry the European Chemicals Agency (ECHA) publishes each month a list of the applications that have been made in accordance with Article 95 but on which ECHA has not yet made a decision whether the application us successful – this is the “Article 95 Pending List”. An active substance supplier is included on the pending list once their application is accepted by ECHA and will remain on the list until the positive or negative decision is taken by ECHA.
The list of pending Article 95 applications should not be confused with the list of Article 95 alternative active substance suppliers ('Article 95 list'). The presence of a company on the pending list does not guarantee that the application will be successful and that the company will be included in the Article 95 list.
No, from the 1 September 2015 Article 95 prohibits a biocidal product being made available on the EU market if the active substance or product supplier is not included on the list of Article 95 alternative active substance suppliers ('Article 95 list').
The Article 95 pending list is a list of applications made the European Chemicals Agency (ECHA). It should not be confused with the list of Article 95 alternative active substance suppliers ('Article 95 list').
Companies on the Article 95 pending list should not be sending out information giving the impression that they/customers buying from them are fully compliant with Article 95 of the EU BPR.
Article 95 of the EU BPR does not prohibit a company from supplying a biocidal active substance in the EU but it does prohibit companies making a biocidal product available on the EU market if they have sourced the active substance in their biocidal product from that company.
Companies on the Article 95 pending list should not be sending out information giving the impression that they/customers buying from them are fully compliant with Article 95 of the EU BPR.
The prohibition in Article 95 the EU BPR is that a biocidal product cannot be made available on the EU market if the active substance or product supplier isn’t included in the list of Article 95 alternative active substance suppliers ('Article 95 list'). If a biocidal product is purely for export outside the EU the requirement the EU BPR, including the prohibition in Article 95 do not apply.
As stated in Article 90 of the EU Biocides Regulation, from the 1 September 2013 ECHA will be responsible for coordinating the evaluation of dossiers and the evaluations will continue.
If the UK CA had finished its assessment the evaluation through the final EU-level stages will continue according to the requirements of the Biocidal Products Directive (BPD).
If the UK CA had not finished its assessment the evaluation will continue according to the requirements of the EU Biocides Regulation. If the evaluation identifies issues due to the requirements of the EU BPR that were not included in the BPD, such as the Exclusion or Substitution criteria in Article 5 and 10, the applicant should be given the opportunity to provide additional information.
Article 5 of the EU BPR specifies criteria that, if an active substance meets those exclusion criteria, it should not be Approved under the regulation for use in biocidal products. These criteria include the active substance being:
If a substance meets any of the criteria it can only be Approved if the applicant can show that the risks from exposure to the substance is negligible, the substance is essential to control a serious danger to human/animal health or the environment, or not approving the substance would have a disproportionate negative impact on society compared to the risks from the use of the substance. Full details of these exclusion criteria are given in Article 5 of the EU BPR and you are advised to look at this Article to see if your active may be affected.
Article 10 of the EU BPR specifies criteria that, if an active substance meets the criteria, it should be considered a candidate for substitution and the availability of alternatives will be taken into account when the decision on Approval of that substance is being made. If such a substance is Approved, products containing it will be subject to comparative assessment. The criteria include:
Full details of these substitution criteria and further information are given in Article 10 of the EU BPR and you are advised to look at this Article to see if your active may be affected.
During the evaluation of an active substance if the evaluating Competent Authority concludes that the active substance meets the criteria for substitution of Article 10 of the EU BPR the European Chemicals Agency (ECHA) will make publicly available information on the active substances so identified as potential candidates for substitution. ECHA will do this before submitting its opinion to the Commission on the approval or renewal of the approval of an active substance.
Article 67 of the EU BPR outlines the information that will normally be published by the European Chemicals Agency (ECHA) once an active substance is Approved. It may be possible for certain information not to be published if the applicant can provide a suitable justification as to why the publication would damage their commercial interests.
The information will be published on ECHA’s website.
Further details of the information that will be published and how to object to its publication is given in Article 67 of the EU BPR
Article 3 defines a biocidal product as
“any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action: or
any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
A treated article that has a primary biocidal function shall be considered a biocidal product.”
A product is considered to be a biocide if it falls within the scope of the EU Biocides Regulation 528/2012 (EU BPR). To determine whether the product falls within the scope of the legislation you should consult our law page for further information and advice.
Biocidal products families build on ‘Frame formulation’ concept under the Biocidal Products Directive (BPD). A biocidal products family is a group of biocidal products that have:
Under the Biocides Regulation all products within the biocidal product family are covered by one authorisation for the family as a whole rather than each individual product requiring authorisation. Each product within the biocidal product family will have a suffix to the authorisation number (Article 17 (6)).
New products can be added to the family if they fall within the existing ranges of the biocidal product family authorisation, Article 17(6) of the Biocides Regulation states that company must notify the relevant Competent Authority 30 days before first placing the new product on to the market. Variations in dyes, perfumes or pigments within existing ranges already established in the family authorisation do not need to be notified.
Article 3 defines a treated article as “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.”
Some articles that contain biocides will be considered to be biocidal products and will therefore need to be authorised under the regulation. Others, whilst not themselves being biocidal products, will be subject to restrictions on what can be placed on the market and may need to be labelled in accordance with Article 58 of the regulations. The labelling requirements came into force from the 1 September 2013, so any articles being put into the supply chain from then should meet those requirements as necessary. There is also a requirement to provide information to consumers, on request, within 45 days which is also in force from 1 September 2013.
No. There is no requirement for food safe certificates under the EU Biocides Regulation 528/2012 (EU BPR) and HSE are not aware of any other EU schemes that would apply.
If a company is asked to provide a food safe certificate for a biocidal product HSE advice is to highlight the transitional provisions of the EU BPR that apply to all biocidal products made available on the UK market. As the products are normally disinfectants these are exempt from the requirements of our existing National legislation, the Control of Pesticides Regulation (COPR) and do not currently require approval in the UK before they are made available on the UK market.
In the future once the active substance(s) in your products are approved you will be required to apply for product authorisation by the approval date of the last active substance in your biocidal product. As part of the authorisation process for the product a risk assessment is carried out to decide if the biocidal product can be used without any undue risk to people, animals or the environment. This risk assessment will take into account where the biocidal product is being used and where the biocidal product may come into contact with food this will be considered as part of the risk assessment. If the biocidal product is authorised its label will then contain health and safety advice associated with the product. If the advice given on the biocidal product label is followed, we would not expect any adverse effects to be experienced following its use. Your authorisation paperwork can then be presented as evidence the biocidal product can be used in food processing environment.
HSE would also like to point out that the advertising requirements of the EU BPR do state that companies advertising biocidal products shall not refer to them in a manner which is misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy. In any case claims that the products is ‘non-toxic’, ‘harmless’, ‘natural’ or any similar indication on the marketing literature for the product would breach the advertising requirements. A similar provision is also found in the packaging and labelling requirements, which will apply in the UK when the product is authorised under the EU BPR.
If you want to place a biocidal product, which falls under the scope of the EU BPR and/or COPR, on to the UK market you must check if you first need to get the product approved/authorised before you place it on the market. If it turns out you do not need to get your product approved/authorised yet, there are some specific provisions of the law with which you may still need to comply.
Further details on checking if you need to get your product approved/authorised, and the other specific provisions are on our placing products on the market page.
If you are unsure which process(es) you need to follow, please consult our law page.
The EU BPR allows for more types of authorisation than were available under the Biocidal Products Directive, these include:
There are also specific permits and notification processes for Parallel Trade and Research & Development
Details of these Authorisation types etc. are given on our EU BPR Product Authorisation Overview page
The costs and timescales will depend on whether your product requires authorisation under EU BPR or approval under COPR.
When HSE receive the application, an initial assessment of the information will be made to determine which type of application it is, whether any additional data is needed, how long it will take to process and how much it will cost.
HSE does not provide a ‘list’ of the substances available for formulators to use. It is your responsibility to check if the active substance you are considering for use in your product has been included onto the EU BPR list of Approved Actives for the relevant product type. If it hasn’t you need to ensure it is being supported for review under the Biocides review programme. (i.e. has it been notified and in the relevant product type).
Details of how to find if a substance is Approved or under review are given on our Checking an Active Substance Status page.
Each biocidal product approved/authorised via HSE is given a unique reference, which must appear on the product label, e.g. HSE 1234 for products granted approval under the Control of Pesticides Regulations (COPR) or UK-YYYY-XXXX-ZZ (where YYYY is year, XXXX is authorisation number and ZZ is suffix for a product in product family, where this is relevant) for products authorised under the EU Biocides Regulation (EU BPR).. Therefore, check the label for an HSE/EU BPR number.
There is a list of products that have been authorised under EU BPR and those previously authorised in the UK before 1 September 2013 via the Biocidal Products Directive route this includes details such as product name, product type active ingredient and authorisation holder/marketing company.
There is a list of products that currently hold an approval under COPR; this includes details such as the product name, active ingredient, marketing company, reference number and use (such as amateur and/or professional). Some COPR products had their approvals revoked when the active substances they contained were approved. These products can continue to be made available on the UK market if the product was issued with a Certificate of Exemption (CoE). Details of these products can be found in our database.
Certificates of Exemption (CoE) were issued to products under the old Biocidal Products Directive (BPD) scheme in the UK when an application was made to get the product Authorised or to withdraw the product from the market following the review of the active substance in the product. They exempted an existing biocidal product from certain requirements of the UK Biocidal Products Regulations (BPR) that implemented the BPD to allow it to remain on the UK market until a decision was made on the application for product authorisation/registration or whilst it was phased-out of the market. Products with extant CoEs at 31 August 2013 were issued new ones from 1 September 2013, but no further CoEs will be issued as under the scheme for the EU Biocides Regulation that applies from 1 September 2013 the UK’s National rules, such as the Control of Pesticides Regulations, will be retained and apply to products until the product is either Authorised or is removed from the market by the relevant deadline.
Products containing active substances included in the EU BPR approved active substance list after 1 September 2013 (including those with BPD Annex I inclusion dates after 1 September 2013) will not be issued with CoEs as the intention is that UK national law such as the Control of Pesticides Regulations (COPR) will still apply to such products until a decision is made to authorise the product under the EU Biocides Regulation so CoEs will not be required for such products.
Products containing active substances included in Annex I/IA of the BPD before 1 September 2013 that had already been issued with CoE’s, had those certificates revoked and replacement CoEs were issued under the new UK Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 from 1 September 2013.
CoEs issued prior to 1 September 2013 and that were extant on 31 August were revoked and replaced with new CoEs from 1 September 2013.
If the active substance(s) in your product has been reviewed under the biocides review programme for your product type and has been included onto the Article 9 list of Approved Active Substance (note, actives previously included onto Annex I/IA of the Biocidal Products Directive were included in the list of Approved Active Substances or the Simplified Annex of the EU Biocides Regulation) then you need to get your product authorised.
When a biocidal product contains more than one active substance the product cannot be authorised under BPR until all of the active substances are Included on to the list of Approved Active Substances.
Until EU BPR authorisation is possible the product must continue to comply with existing UK national legislation and general requirements as outlined on our placing biocidal product on the Existing UK Legislation page.
If the active substance in your product is listed in a non approval decision for your product type, you can’t use it in biocidal products placed on the EU market after the date stated in the non inclusion decision; this will normally be:
NOTE: The 12 months period for making the product available on the market relates to all making available of the biocidal products from the top of the supply chain (e.g. manufacturer or formulator) down to when the user receives it (e.g. from a distributor or retail store/website).
You must manage the supply of the affected product to ensure there will be none remaining in the EU supply chain by the relevant date in the non approval decision.
If your active substance was not even Notified for review under the biocides review programme then the product cannot be marketed or used.A possible exception would be where the product was not within scope of the Biocidal Products Directive but has been brought into scope of the EU Biocides Regulation. Details of such products and the actions that need to be taken are given on our Newly Under Scope page.
As stated in Article 92 of the EU Biocides Regulation, the product is considered as authorised in accordance with Article 17 of the EU Biocides Regulation. The authorisation/registration granted prior to 1 September 2013 under the UK BPR (which implemented the Biocidal Products Directive (BPD)) is still valid and its conditions and restrictions still apply until its expiry date or until the authorisation/registration is revoked or cancelled.
From the 1 September 2013 the requirements of the EU Biocides Regulation will also apply, including the requirements for Advertisements, Record Keeping, Article 95 (approved active substance suppliers) and providing information to the National Poisons Information Service. The Packaging and Labelling requirements also apply instead of the requirements of the UK BPR (which implemented the Biocidal Products Directive).
Yes your application for amendment will be processed under the procedure/process outlined in Article 48 or 50 of the EU Biocides Regulation and the Changes Regulation (Regulation (EU) No 354/2013) . The terms and conditions of your authorisation will be updated to being them in line with the requirements the EU Biocides Regulation.
The evaluation our your application will continue according to the requirements of the Biocidal Products Directive (BPD) but authorisation will granted under the EU Biocides Regulation. The evaluation will take into account the requirements of the EU BPR, such as the conditions for granting an authorisation Article 19 and comparative assessment Article 23. If the evaluation identifies issues due to the requirements of the EU BPR that were not included in the BPD, the applicant should be given the opportunity to provide additional information.
Article 67 of the EU BPR outlines the information that will normally be published by the European Chemicals Agency (ECHA) once an active substance is Approved or a biocidal product is Authorised. It may be possible for certain information not to be published if the applicant can provide a suitable justification as to why the publication would damage their commercial interests.
The information will be published on ECHA’s website.
Further details of the information that will be published and how to object to its publication is given in Article 67 of the EU BPR .
HSE, local authorities and several other bodies have roles in investigating incidents and carrying out enforcement for the Control of Pesticides Regulations (COPR) and the Biocidal Products Regulations (BPR). Depending on where the product has been used the use of biocidal products is usually enforced by either HSE inspectors or local authority environmental health officers. More detailed information on the specific enforcing authority for a particular situation is given on our Enforcement page.
If you, your family, your pets, or wildlife have been affected by exposure to biocides you are advised to seek medical advice as necessary and then to report the incident to the appropriate authorities. The department to contact depends on the type of incident that you wish to report.
Biocides are subject to a risk assessment to decide if they can be used without any undue risk to people, animals or the environment. The label on an approved/authorised product contains health and safety advice associated with the product.
If the advice given on the product label is followed, we would not expect any adverse effects to be experienced following the use of an approved/authorised product.
However, if somebody (human or animal) does become ill or is adversely affected after a biocide has been used please see the information and advice on our Reporting Incidents of Exposure page.
All users of biocides must be trained and competent for the tasks they are required to perform. There is no requirement for a user of biocides (or non-agricultural pesticides as they are referred to under COPR) to have gained a 'certificate of competence'.
However, the law says that if a person is using a biocide in the course of their business then they must have received appropriate information, instruction and training in the use of biocides.
The type of training required/received would cover issues such as the legislation, the correct use of biocides and how to carry out a risk assessment under the Control of Substance Hazardous to Health Regulations (COSHH). Those using biocides have a duty to properly assess a situation before they use a biocide, and consider the options for treatment and the potential risks involved, to ensure that a product is used in a way that reduces any risks from its use.
There are numerous courses run around the UK on different aspect of biocide use, both by private consultants and firms and by trade associations and training bodies.
We cannot recommend any specific company, as we must remain impartial. However, we would recommend that you either contact your local council to see if they will carry out the treatment you require or you could contact one of the Pest Control Trade Associations to see if they can recommend a pest control company.
We cannot recommend any specific products, as we must remain impartial to all companies that have products approved/authorised. However, there is a wide selection of products available and these may be found in local DIY/hardware stores and supermarkets.
There is a list of products that currently hold an approval/authorisation on the HSE website. This includes details such as the product name, active ingredient, marketing company, HSE number and use (such as amateur and/or professional).
See question "How can I find out if a product is already approved/authorised?" for further details about our databases.
Honey bees, both feral (wild) and colonised, are important beneficial insects, not normally considered as pests. They live either in the wild in nests, or as colonies in hives kept by beekeepers. In either case, they will only sting people if strongly provoked.
Because of their beneficial role, every effort should be made to avoid carrying out control treatments against honey bees. Treatment with a pesticide should be considered only as the last resort.
If you are asked to treat a feral honey bee nest, you should assess the situation carefully. Have people been stung by honey bees from the nest, or are they at risk because of its location? If the nest is not causing any risk to public health then you should carefully consider the alternatives before carrying out a treatment. If you are a member of the public, it may be better to consult a Professional Pest Controller rather than attempting to treat a nest yourself – see the question ‘Can your recommend a Pest Control Company’ for further details of contacting a Professional Pest Control company.
If you consider treatment is the best option, make use of the British Beekeepers Association's spray liaison scheme. This will enable local beekeepers to be warned by their own Spray Liaison Officer. It is important for you to talk to local beekeepers in this way before treating a nest.
Remember, members of the British Beekeepers Association can provide advice and can sometimes remove accessible feral honey bee colonies, avoiding the need to use pesticides.
Only use an HSE approved insecticide. Always read the label and use the product safely.
Once the treatment is complete, you should take every reasonable action to prevent foraging honey bees from gaining access to the treated nest, by removing the combs or blocking the nest entrances.
Placing on the market is defined in the EU Biocides Regulation as “the first making available on the market of a biocidal product or of a treated article”.
Making available is defined in the EU Biocides Regulation as “any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge”
Use’ is defined in the EU Biocides Regulation as “all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union”.
All the product types that where previously under the Biocidal Products Directive (BPD) are within the scope of the Biocides Regulation with exception of preservatives for food and feedstock (product type 20 under the Biocidal Products Directive) which have been removed as such preservatives are covered other EU legislation. Some descriptions of Product Types have also been changed/expanded.
In-situ biocides, both those generated from supplied precursors and those where no precursor is supplied, are now clearly in scope of Biocides Regulation.
The Biocides Regulation also make it clear that the review of an existing active substance will only cover nano forms if data has been submitted on those nano-materials.Treated Articles page.