What is the BPD?
In 1993, the European Commission proposed a Directive to establish a single European market in biocides by introducing a harmonised authorisation system based on assessment of risks to people and the environment, together with a consideration of efficacy. This became the Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market – commonly known as the ‘Biocidal Products Directive’ (BPD) or simply the ‘biocides directive’. The BPD entered into force on 14 May 2000.
The Directive has two central aims:
- to harmonise the European market for biocidal products and their active substances so that once a product is authorised in one Member State under the Directive that authorisation can be recognised in the other Member States;
- to provide a high level of protection for people, animals and the environment.
Each European Union Member State is responsible for implementing the BPD into their national law. In Great Britain the BPD is implemented through the Biocidal Products Regulations (BPR) 2001, which came into force on 6 April 2001. The BPD was implemented in Northern Ireland through the Biocidal Products Regulations (Northern Ireland) 2001 on 16 January 2002.
There have been further amendments to BPR, in 2003, 2005 and 2007.
What is a biocide/biocidal product?
The Biocidal Products Directive (BPD) gives a formal definition of biocidal products as:
"Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means."
Therefore, despite the name ‘biocide’, a biocidal product does not actually have to kill. If it is used to destroy, deter, make harmless, or control a harmful organism by chemical or biological means it may be considered a biocide. For example, a repellent used to ‘deter’ a mosquito could be considered a biocidal product.
What types of product are covered by the BPD?
The scope of the BPD is very wide, covering 23 different product types. These include disinfectants for home and industrial use; preservatives for manufactured and natural products; non-agricultural pesticides for use against insects, rodents and other vertebrates and specialised products such as embalming/taxidermist fluids and antifouling products. A full list of product types is in Annex V of the BPD.
The BPD excludes the non-biocidal uses of products and active substances. It also does not apply to products regulated under certain other European legislation including plant protection products, human medicines, veterinary medicines, medical devices or cosmetics. Article 1 of the BPD and Schedule 2 of BPR gives a full list of the exempting legislation.
Where scope is unclear, issues can be discussed at EU level. When the EU Commission finalises decisions on scope issues they are included in the 'Manual of Decisions'.
There are also borderline documents available on scope issues relevant to the BPD, including the borderlines between the BPD and other legislation covering Medicines, Veterinary Medicines, Cosmetics and Plant Protection Products. These documents are agreed between the between the Commission services and the competent authorities of Member States to provide guidance to Member States on borderline cases for the BPD and other Directives.
If, having read these borderline documents, you are still unsure whether your product may be covered by one of these other pieces of legislation then please check with the relevant regulatory authorities for those pieces of legislation who can advise you further.
How does the BPD work?
The BPD achieves its aims using a two-stage regime involving rigorous evaluation of both biocidal active substances and biocidal products, to ensure they pose no unacceptable risks to people, animals or the environment.
Ultimately, only those biocidal products, which contain an active substance, which is included in Annex I of the BPD, will be authorised for use. Active substances have to be evaluated to determine whether they will be included in Annex I. This requires industry to submit data that is evaluated by Member States with decisions over Annex I inclusion being taken at the European level. Industry is charged a fee for this process, which varies dependent on the Member State.
Once an active substance has been included in Annex I, Member States can authorise products containing it in individual Member States (providing that any necessary data has been supplied and any conditions put on Annex I inclusion are met). Once a product has been authorised in the first Member State, it will be possible for it to be mutually recognised and therefore authorised by other Member States (providing relevant conditions are similar). However, there will have to be an application to other Member States, and again there will be fees for these processes, though the fees should be lower than for the first authorisation.
What is Annex I of the BPD and where can I find it?
Annex I is a list of active substances that have been assessed and considered to be acceptable for use in biocidal products. Once a review of a biocidal active substance is complete a decision will be made as to whether or not it gains Annex I inclusion.
[back to top]What is the biocides review programme?
Biocidal active substances on the market when the BPD came into force (14 May 2000) have to be reviewed to ensure they can be used without unacceptable effects to people, animals or the environment, following which individual products containing them have to be authorised. These biocidal active substances are referred to as ‘existing’.
The programme for the review of ‘existing’ biocidal active substances is controlled by a series of EU Commission Regulations, available on the European Union website regulation page, with more information under the ‘Review of existing substances’ menu. The review programme as a whole is expected to last 10 years from when the BPD came into force but it may take longer.
Further information on the Review Regulations
First Review Regulation
The First Review Regulation (EC/1896/2000) entered into force on 28 September 2000.
This stated that Industry (by a closing date of 28 March 2002) could either Identify active substances that were used in biocidal products, or Notify their intention of supporting the active substance in specific product types in the review programme.
This also gave the product types for the first priority list as rodenticides (Product Type 14) and wood preservatives (Product Type 8). The full dossier of all the data and other information for these product types had to be submitted to the ‘Rapporteur’ Member State by 28 March 2004 – the Rapporteur being the country that carries out the dossier assessment.
The Rapporteur Member State allocation for the first priority list (Product Types 8 and 14) is given in the Second Review Regulation.
The Prolongation Regulation
The Prolongation Regulation (EC/1687/2002), gave an additional period, until 31 January 2003, during which industry could Notify active substances that had previously only been Identified, or for active substances that had already been Notified, to expand the Notification to include further product types.
Second Review Regulation
The Second Review Regulation (EC/2032/2003), entered into force on 14 December 2003.
This includes lists of Identified existing active substances (in Annex III) and Notified existing active substances and the product types in which they were Notified (in Annex II). It gives information on the continued supply of biocidal products. If an active substance was:
- Neither Identified nor Notified then products containing them had to be removed from the EU market by 14 December 2003.
- Identified but not Notified, or Notified but not in a certain product type, such products had to be removed from the EU market by 1 September 2006.
- Notified for use in a product type then products containing it can be placed on the market (subject to any requirements under existing national legislation), until the review has been completed.
This also gives the First and Second priority lists in the review program and the associated Rapporteur Member States and the product types for the third and fourth lists.
Third Review Regulation
The Third Review Regulation (EC/1048/2005), entered into force on 13 June 2005.
This amends the Second Review Regulation and:
- Gave the opportunity for an active substance, which had been Identified or Notified but not for use in a particular product type, to be upgraded to the 'Notified' status by submitting a full dossier for review on the active substance and a representative product containing it by 1 March 2006 (via Article 4b).
- Updates the list of Notified existing active substances and the product types in which they were Notified in Annex II.
- Allocates Rapporteur Member States for the active substances in the Third and Fourth priority lists.
- Lays down the concept of essential use, whereby Member States may apply to the Commission for an extension of the 1 September 2006 deadline where they consider that an active substance that should be removed from the market on that date is essential for them for reasons of health, safety, protection of cultural heritage or is critical for the functioning of society, and where there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.
Further information on “essential use”
Fourth Review Regulation
The Fourth Review Regulation (EC/1849/2006), entered into force on 14 December 2006.
This introduces the following amendments:
- It lays down the concept of 'assessment report', which is the final form of the report on the evaluation carried out by the Rapporteur Member State; once the competent authority report has been peer reviewed and the evaluation completed. It also lays down that the assessment report shall be made publicly available.
- It stipulates that, after 1 September 2006, biocidal products containing substances, for which decisions will have been taken to no longer include them within the review programme, shall be withdrawn from the market within 12 months of such decisions coming into force.
- It updates Annex III of Regulation 2032/2003 to remove the entries of the BKC- / DDAC-related substances, which are thus allowed to remain on the market, for the product-types Notified, after 1 September 2006 and until they have been evaluated under the review programme. Clarification paper on QUATS (BKC and DDAC)
- It updates Annexes II and III of Regulation 2032/2003 further to the submission of applications in accordance with Article 4b of Regulation 2032/2003.
The Fifth Review Regulation
The Fifth Review regulation (1451/2007/EC) came into effect on the 24/12/2007. It updates and replaces the Second Review regulation (2032/2003/EC and its amendments (1048/2005/EC and 1849/2006/EC (the Third and Fourth review regulations))).
The main changes this regulation makes are:
- It allows for the removal from consideration of Animal and Human foodstuffs marketed as Attractants or Repellents (product type (PT) 19, i.e. honey, jam) until the end of the end of the review period, at present 14th May 2010. These substances are defined in Article 6.
- When a non-inclusion decision has been published for a substance in a particular product type, then from the date of publication there is a 12 month phase out from sale period, (See article 4 (2)).
- When support has been withdrawn for a substance in the review programme, it states that it can be taken over by another participant. This must happen within the 3 month period as outlined by the Commission. This change of support can only happen on one occasion. (See Article 12). So if you have an interest in taking over support of a substance, you must do it within this 3 month period otherwise it will be withdrawn from the review process and would then have to be treated as a new active.
- Where a substance is supported through the review, others apart from the original Applicant may submit dossiers to support the active. However, they will have to work to the same timescale as the original submission. (See Articles (7) and (8)).
- The Fifth regulation provides updated and simplified Annexes for existing chemicals, the Member States responsible for evaluation and the product types that support has been registered under.
The 5th review regulation should now be used to check substance notification under the review programme as it replaces previous review regulations.
When are biocidal active substances going to be reviewed?
The European Commission and the Member States agreed that active substances would be reviewed by product type and under Four Priority Lists – see Table 1.
| Priority Lists | Submission Deadline | Product Types |
|---|---|---|
| First | 28.03.2004 | 08 Wood Preservatives 14 Rodenticides |
| Second | 01.05.2006 | 16 Molluscicides 18 Insecticides, acaricides and products to control other arthropods 19 Repellents and attractants 21 Antifouling products |
| Third | 01.08.2007 | 01 Human hygiene biocidal products 02 Private area and public health area disinfectants and other biocidal products 03 Veterinary hygiene biocidal products 04 Food and feed area disinfectants 05 Drinking water disinfectants 06 In-can preservatives 13 Metalworking-fluid preservatives |
| Fourth | 01.11.2008 (no earlier than 1 May 2008 and no later than 31 October 2008) |
07 Film preservatives 09 Fibre, leather, rubber and polymerised materials preservatives 10 Masonry preservatives 11 Preservatives for liquid-cooling and processing systems 12 Slimicides 15 Avicides 17 Piscicides 20 Preservatives for food or feedstocks 22 Embalming and taxidermist fluids 23 Control of other vertebrates |
The submission deadlines are also found in the Second Review Regulation in Parts A (for Product Types 8 and 14), Part B (for Product Types16, 18, 19 and 21), Part C for Product Types 1, 2, 3, 4, 5, 6 and 13 and Part D for Product Types 7, 9, 10, 11, 12, 15, 17, 20, 22 and 23.
The Rapporteur Member States for the review of active substances are found in Annex II of the Fifth Review Regulation, indicated by an abbreviation code in the column next to the active ingredient name.
Lists of withdrawn active substances and the related product types where participants have withdrawn from the biocides review program are available on the European Union website.
Abbreviation codes for Rapporteur Member States
| Austria | A or AT | Latvia | LV | |
|---|---|---|---|---|
| Belgium | B or BE | Lithuania | LT | |
| Cyprus | CY | Luxemburg | L or LU | |
| Czech Republic | CZ | Malta | MT | |
| Denmark | D or DK | Poland | PL | |
| Estonia | EE | Portugal | P or PT | |
| Finland | FI or FIN | Slovakia | SK | |
| France | F or FR | Slovenia | SI | |
| Germany | DE | Spain | E or ES | |
| Greece | EL | Sweden | S or SE | |
| Hungary | HU | The Netherlands | NL | |
| Ireland | IE or IRL | United Kingdom | UK | |
| Italy | I or IT |
What is an existing biocidal active substance and what is a new biocidal active substance?
All biocidal active substances, which were on the EU market before the BPD came into force (14 May 2000) and which were Notified or Identified according to the Commission Regulation EC/1896/2000 (the First Review Regulation) are considered to be existing biocidal active substances. Biocidal active substances, which were not on the EU market before the 14 May 2000 and were not Notified or Identified, are considered to be new biocidal active substances, which will have to be assessed according to the BPD before biocidal products containing them can be placed on the EU market.
What is Identification and Notification and what is the difference between an Identified and a Notified existing biocidal active substance?
The First Review Regulation (EC/1896/2000) required industry to inform the EU Commission by 28 March 2002 of their intentions with respect to the biocides review programme. They could either Identify or Notify an existing active substance.
Identification
If industry did not intend to support an active substance through the BPD review programme they had the option to Identify that substance by providing the information specified in Annex I of the First Review Regulation, such as its identity, uses etc. This allowed biocidal products containing that substance to be marketed until 1 September 2006.
Notification
An active substance could be Notified where industry intended to support it through the BPD’s review programme for possible inclusion in Annex I of the BPD. They had to supply the information specified in Annex II of the First Review Regulation, which required submission of summary data on the essential hazards of the active substance, and a full dossier is to be provided in the next phase of the review.
These Notified substances are listed, along with the product types the Notifier intended to support them in, in Annex II of the Second Review Regulation and an updated list in Annex II of the Third Review Regulation.
Biocidal products marketed in the notified product types can stay on the EU market until the actives have been reviewed and a decision is made as to whether or not they are included on Annex I of the BPD.
Where can I find out if an active substance has been Identified or Notified?
The lists of those active substances that have been identified or notified are in the Fifth Review Regulation available on the European Union website: active substances.
Searches can be carried out by CAS/EC numbers of the active substance to find which list (Annex) the active substance is listed on.
In the Fifth Review Regulation, Annex I is the list of Identified and/or Notified active substances. (NB This is not the Annex I of the BPD) and Annex II is the list of only Notified biocidal active substances with the related product types.
The Fifth Review regulation updates and replaces the Second Review regulation (2032/2003/EC and its amendments (1048/2005/EC and 1849/2006/EC (the Third and Fourth review regulations))) therefore it should now be used to check substance notification under the review programme as it replaces previous review regulations.
Lists of withdrawn active substances and the related product types where participants have withdrawn from the biocides review program are available on the European Union website.
A consolidated lists of the active substances and the related product types where a non-inclusion decision has been published is available on the European Union website: non-inclusions.
What are the consequences of Identification and Notification?
If an active substance:
- was neither Identified nor Notified - then it cannot be used in biocidal products placed on the EU market. Companies wishing to market an active substance which was neither Identified nor Notified would have to apply for the active substance to be assessed as a 'new' active substance for possible inclusion on Annex I. Biocidal products containing that active substance can not be placed on the EU market until the assessment is complete and a decision is made for Annex I inclusion. However, provisional authorisation may be granted for products containing an active substance not yet on Annex I, but for which the evaluating Member State has evaluated an application and recommended Annex I inclusion;
- was only Identified but not Notified, or Notified but not in the relevant product type - Biocidal products containing it had to be removed from the EU market by 1 September 2006. Companies wishing to market an active substance which was only Identified but not Notified, or Notified but not in the relevant product type would have to apply for the active substance to be assessed as a 'new' active substance for possible inclusion on Annex I. Biocidal products containing that active substance can not be placed on the EU market until the assessment is complete and a decision is made for Annex I inclusion. However, provisional authorisation may be granted for products containing an active substance not yet on Annex I, but for which the evaluating Member State has evaluated an application and recommended Annex I inclusion;
- was Notified for use in my product type - Biocidal products containing that active substance can be placed on the EU market (subject to any requirements under existing national legislation in a Member State), until the review has been completed. If following review, an active substance is included on Annex I of the BPD, then those companies who supply biocidal products containing that active substance will require authorisations for those products if they are to remain on the market. If inclusion in Annex I is not possible then products containing that active substance will have to be removed from the EU market.
- Please note that although an active substance may have been notified and in the relevant product type, it is important that you check
- the lists of withdrawn active substances and the related product types where participants have withdrawn from the biocides review program or where someone has taken over the role of participant; and
- the consolidated lists of the active substances and the related product types where a non-inclusion decision has been published.
- Please note that although an active substance may have been notified and in the relevant product type, it is important that you check
These lists will help to determine when an active substance and biocidal products containing that substance has to be removed from the EU market. The withdrawn lists and the consolidated lists for the non-inclusion decisions are available on the European Union website.
What do I need to do when applying for a ‘new’ active substance under the BPD?
‘New’ active substances are biocidal active substances which will require Annex I inclusion of the BPD before they can be supplied anywhere within the EU for use in biocidal products.
The application for a new active substance must include a dossier of information on the active substance and a dossier on at least one product for each product type containing the active substance. Application dossiers are packages containing all the necessary and relevant information required by a Competent Authority (CA) to evaluate whether Annex I inclusion is appropriate for that active substance.
The data requirements are outlined in Annexes II and III of the BPD and there are Technical Notes for Guidance on Data Requirements available on the European Chemicals Bureau website.
A company wishing to apply for a new active substance under the BPD can chose which country they want to submit their application to, and should contact the relevant Competent Authority (CA) regarding the application as they can advise on any requirements the application may require in addition to those outlined in the core data requirements.
In the UK, HSE acts as the CA. HSE fees are based on actuals, meaning that if less time was spent on an evaluation the calculated difference will be refunded, whereas if more time was spent on an evaluation, a further fee to cover the work may be charged.
Is the information required for a ‘new’ active substance the same as that for an existing active substance which is being supported in the biocides review programme?
Yes, the information required for a new active substance and an existing active substance in the biocides review programme is essentially the same. The data requirements are outlined in Annexes II and III of the BPD.
When applying for a ‘new’ active substance then you can choose when and to which Member State you submit your application.
In the biocides review programme existing active substances are assigned to a Member State with set deadlines for dossier submission and evaluation.
What is the BPD ‘Transitional Period'?
The BPD ‘Transitional Period’ is where existing biocidal active substances are in the process of transferring from EU Member States older, national legislation to regulation under the BPD. This is being carried out by the biocides review programme, where Notified biocidal active substances are being reviewed in groups according to their intended uses. During this transitional period, existing national legislation in Member States on the marketing of biocidal products will continue to apply until such a time as biocidal active substances are included, or a decision is taken to refuse inclusion, on Annex I of the BPD.
If I want to place a product on the UK market and my active substance has been notified for use in my product type - what do I need to do now?
- Inform the National Poisons Information Service (NPIS) and do this before you begin to sell the product in the UK. The NPIS is an organisation supported by the Department of Health, which is responsible for providing a year-round service for health care staff on the diagnosis, treatment and management of patients who may have been poisoned. The Birmingham Centre is responsible for receiving and disseminating product safety information for pesticides, agrochemicals, biocides and veterinary products marketed in the UK. By providing information to NPIS, you are ensuring up to date information is quickly available to health care professionals to allow them to diagnose and treat any cases of poisoning by biocidal products, which may occur.
The information required by the NPIS is listed in Schedule 8 of the Biocidal Products Regulations (BPR) and you can also find a list of the required information and contact details for the NPIS at: http://www.hse.gov.uk/biocides/bpd/informing.htm. - Check your liability for the General Industry Charge (GIC). The GIC applies if you are the first person to place a biocidal product onto the UK market for the end user or if you are supporting an active substance in the biocides review programme and have placed the active substance on the UK market. Further information on the GIC. If you consider you are liable then you should complete the GIC registration form and return this to HSE.
- As we are in a transitional period, if your active substance has been notified for use in your product type then you must comply with any existing UK regulatory schemes for biocidal products that may apply for your product type.
- Comply with the requirements in the Biocidal Products Regulations (BPR) 2001, that relate to advertising - these are laid down in regulation 33 of the BPR. Previously, products were exempt from these requirements until they were authorised under the BPR. However, under the Biocidal Products (Amendment) Regulations (BPR) 2007 companies must now comply with the requirements for advertising for their biocidal products. These do not apply to the packaging and labelling of biocidal products. There are specific requirements for packaging and labelling laid down in regulations 30 and 31 of BPR and these do not come into force until products are authorised under BPR. The advertising requirements are as follows -
A person who places a biocidal product on the market shall ensure that any advertisement for that biocidal product
- subject to paragraph (2), contains the sentences "Use biocides safely. Always read the label and product information before use." and these words shall be clearly distinguishable from the rest of the advertisement. The word ‘biocides’ may be replaced by the product-type of the biocidal product
- does not refer to the biocidal product in a manner likely to mislead in respect of the risks of that biocidal product to humans, animals or the environment
- does not contain, in relation to the biocidal product, the descriptions "low-risk biocidal product", "non-toxic" nor "harmless", nor similar descriptions
A failure to comply with this is a breach of BPR.
Are there any existing UK regulatory schemes in place for biocidal products?
In the UK, if your active substance has been Notified for use in your product type then you must comply with any existing UK regulatory schemes for biocidal products that may apply for your product type whilst the substance is being reviewed.
For example in Great Britain, Non-Agricultural Pesticides (such as wood preservatives, masonry/surface biocides, antifouling products, public hygiene insecticides, rodenticides and other vertebrate control agents, some repellents, avicides) are regulated under the Control of Pesticides Regulations 1986 (COPR) (as amended) and will continue to be regulated and approved via HSE under this scheme until they are reviewed under the BPD.
There is a current UK scheme in place for veterinary disinfectants for use against pathogenic organisms. This is overseen by DEFRA who are the body that 'approve' and list disinfectants (via results of laboratory based efficacy testing) under the Diseases of Animals (Disinfectants Approvals) Order 1978 against diseases such as Foot-and-mouth Disease, Swine Vesicular Disease, Tuberculosis etc.
There is a current regulatory scheme in place for substances and products used in drinking water. Drinking water quality in England and Wales is regulated by the government through the Drinking Water Inspectorate (DWI). Drinking water disinfectants are covered by the BPD (Product-type 5), and so responsibility for their authorisation will transfer from DWI to HSE. The existing national arrangements for the approval of existing products under DWI will continue for any given product until the active substance(s) in it has been reviewed under the BPD and a decision is made on whether or not it gains Annex I inclusion.
The majority of other biocidal products are not currently regulated in the UK by specific legislation but are covered by general chemical legislation which continues to operate. For example, the Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP).
In addition, the General Product Safety (GPS) Regulations, which the Department of Business Enterprise and Regulatory Reform (BERR), (formerly known as the Department of Trade and Industry), are responsible for may apply. These regulations place a general duty on all suppliers of consumer goods to supply products that are safe in normal or reasonably foreseeable use. Further information on the GPS Regulations.
If a product is under the scope of BPD and also under the national UK scheme for non-agricultural pesticides - the Control of Pesticides Regulations (COPR) - what do I need to do?
The BPD and the UK Biocidal Products Regulations (BPR) will eventually replace current national controls on biocidal products. Once the use of an active substance in a specific product type has been reviewed, products containing it will become controlled under BPD/BPR. In the UK, once an active substance has been reviewed for its use in, for example, wood preservation, then any wood preservative products containing it will become controlled under the BPR rather than the COPR, and any existing COPR approvals will no longer apply. However, until that point COPR still applies and product approval is required before the product is advertised, sold, supplied, stored or used.
What will happen once an active substance is included on Annex I of the BPD?
Once an active substance gains Annex I inclusion then those companies who supply biocidal products containing that active substance will be required to gain authorisation for their products under BPD/BPR if they intend for them to remain on the market.
Once an authorisation has been granted by one Member State, then authorisation may subsequently be granted in other Member States upon application, unless there are specific grounds to derogate. This is known as mutual recognition.
Applicants for authorisation will require:
- a letter of access to the dossier supporting Annex I inclusion of the active substance in their biocidal product (or they can provide their own active substance dossier) and
- either a product dossier or a letter of access to one, for their biocidal product. The product dossier will need to meet the requirements set out in Annex IIB and relevant parts of IIIB of the BPD.
A list of participants seeking review of an active substance can be found at: http://ec.europa.eu/environment/biocides/pdf/list_participants_applicants.pdf.
Once specific information on the authorisation/registration of biocidal products under the UK Biocidal Products Regulations is available, we will publish this on our website.
How are the UK Biocidal Products Regulations enforced?
In the UK, the Biocidal Products Regulations, made under the Health and Safety at Work etc. Act 1974 (HSWA) and the European Communities Act 1972 are enforced by both HSE and local authority inspectors/trading standards officers.
Enforcement for the supply of biocidal products and active substances is carried out by the local weights and measures authorities (usually Trading Standards Officers), who also have the responsibility for enforcing the regulation on advertisements
The proper use of products in commercial and industrial undertakings is enforced by HSE and local authority inspectors as determined by the Health and Safety (Enforcing Authority) Regulations 1998.