Checking an Active Substance Status under the EU Biocides Regulation 528/2012 (EU BPR)

The active substance / product type combination has been reviewed and an approval decision has been published.

The ECHA table will also provide,

• a link to the Implementing Regulation approving the active substance / product type combinations.
• a link to the Assessment Report and to non-confidential data on the active substance / product type combinations.
• The date of approval, which might be in the future or have already passed.
  • If the approval date (for all the active substances in the product) has passed you will have to apply for and receive product authorisation before the biocidal can be placed on the UK market.
  • If the approval date is in the future then you need to apply for product authorisation by the approval date for that active substance / product type combination. If the biocidal product contains more than one active substance then the date of approval of the last active substance in that biocidal product is the date by which you need to apply for product authorisation.
    
    Under the transitional provisions of Article 89 of the EU BPR, until the approval date for the active substance /product type combination you can make the biocidal product available in the UK, complying where necessary with the requirements of relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR. See our Existing UK National Legislation page for more information.

The active substance / product type combination is not yet approved but an application for the approval of the active substance has been submitted.

The list of active substances "under review" in the ECHA table currently – and confusingly – includes both new and existing active substances. If a biocidal product contains a new active substance this active substance / product type combination must be approved and the biocidal product authorised before the biocidal products can be made available on the UK market. HSE has asked ECHA to correct their table to make it clear which actives are actually ‘new’ and which are existing actives that are under review in the review programme, but until that happens you will need to check if an active listed as “under review” is included in the review programme.

To check which active substance / product type combinations are included in the Review Programme, please refer to Annex II, Part I (page 14 to 28) of the EU BPR Review Regulation (Commission Delegated Regulation (EU) No 1062/2014). Using the CAS or EC number as the search term is usually the most effective way to search for a substance in the review regulation. Details on how to search the EU BPR Review Regulation can be found below. For further information about the EU BPR Review Regulation see our Review Regulation page.

If all the active substances are under review for the relevant product type you can make the biocidal product available in the UK, complying where necessary with the requirements of relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR. See our Existing UK National Legislation page for more information.

Also please note although the active substance is under review the status of the active substance will change as the active substance progresses through the biocides active substance review programme, for example it might get approved, not approved or withdrawn. Therefore you should regular check the status of the active substance(s) in your biocidal product.

The active substance / product type combination has been under review and a non-approval decision has been published.

Non-approval decisions are taken when,

• an active substance / product type combination has been evaluated and as a result of the evaluation it has been decided that an active substance / product type combination should not be used in biocidal products placed on the EU market; or
• either all participants have discontinued their participation from the review programme, or no complete dossier was received within the time period specified.

Biocidal products containing active substances for which a non-approval decision has been taken can be made available on the UK market but only until the deadlines referred to in the decision/Article 89 of the EU BPR; this will normally be:

• 12 months from the date of the decision for making the product available; and
• 18 months from the date of the decision for its use.

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). Therefore once the 12 month period has expired there should be no supply of an affected product anywhere in that supply chain.

Where a product has more than one active substance, for example one or more still under review or Approved and one or more subject to a non-approval decision, then the product will still have to be removed from the market and from use by the 12 and 18 months deadlines referred to in Article 89 of the EU BPR.

During the phase-out period, the biocidal product must comply where necessary with the requirements of any relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR during the phase out periods. See our Existing UK National Legislation page for more information.

If the active substance in your product isn’t listed in the ECHA table it could mean that the active substance hasn’t been supported for the relevant product type and therefore you cannot use it as an active substance in a biocidal product to be made available on the EU market. This also applies if you have more than one active substance in your product and any one of them has not been supported for the relevant product type.

You could choose to submit the relevant data for the substance to be assessed and approved under the EU BPR but it could not be used as an active substance in biocidal products placed on the EU market until that assessment is complete. Further details on supporting an active substance are on our Active Substance Approval page.

However it might not be listed in the ECHA table because

• your biocidal product is one of those that was not within scope of the Biocidal Products Directive (BPD) and is newly within scope of the EU BPR. See our newly under scope page for further information about how to support these active substances.
• your biocidal product is affected by the redefining exercise for in-situ generated biocides. See our in-situ generation webpage for further information about how to support these active substances.
• the active substance is subject to a withdrawal notice or an European Chemicals Agency Open Invitation. See the section on withdrawal notice under the heading EU BPR Review Regulation for further information.

You may have found your active substance is listed as “under review” in the ECHA Biocidal Active Substances table. To check if an active substance has been supported for assessment under the EU BPR review programme or if it is a new active substance you need to go to the EU BPR Review Regulation (Commission Delegated Regulation EU 1062/2014). Part 1 of Annex II to the EU BPR Review Regulation (page 14 – page 28) lists all the active substance/product type combinations supported for assessment in the review programme and still undergoing assessment on 4 August 2014(excluding any nano-material forms other than those explicitly mentioned). You can easily recognise Annex II as it is a table with 23 columns; the first five columns being ‘Entry number’, ‘Substance’, ‘Rapporteur Member State’, ‘EC Number’, ‘CAS Number’ and then numbered columns which represent the product types.

To find out which product types an active substance was notified for we recommend that you check its status by searching using its CAS or EC number. However, it is important that the result found for the active substance is its entry in Part 1 of Annex II to the EU BPR Review Regulation (page 14 – page 28) and that it relates to the relevant product type for your product. For example, if an active substance was notified for product type 18 there will be a cross in the relevant box in the table for its entry.

Please note Part 2 of Annex II to the EU BPR Review Regulation is a list active substance/product type combination that were previously supported for assessment, but all have been withdrawn from the biocides review programme ("Withdrawal Notice"), see below for more information about Part 2 of Annex II to the EU BPR Review Regulation.

If all the active substances are under review for the relevant product type (listed in Part 1 of Annex II to the EU BPR Review Regulation (page 14 – page 28)) you can make the biocidal product available in the UK, complying where necessary with the requirements of relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR. See our Existing UK National Legislation page for more information.

Also please note although the active substance is under review the status of the active substance will change as the active substance progresses through the biocides active substance review programme, for example it might get approved, not approved or withdrawn. Therefore you should regular check the status of the active substance(s) in your biocidal product.

A number of active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme. Details of these active substance/product type combinations can be found in “Withdrawal notice” of the EU BPR Review Regulation (Part 2 of Annex II) or in "Open Invitations" published on the European Chemicals Agency website.

Withdrawl notice

The EU BPR Review Regulation includes, at Part 2 of Annex II (page 28 to 33), details of active substance/product type combinations that are no longer considered to be in the biocides active substance review programme, and this is the "withdrawal notice" for these active substance/product type combinations.

Nano-forms of active substance/product type combinations listed in Part 1 of Annex II are no longer considered to be included in the review programme (with the exception of specific nano-forms of entries 1017 and 1019), the review regulation also allowed the opportunity for new participants to take over support for nano-forms of those active substances.

Anyone wishing to take over the role of participant of these active substance/product type combinations had to complete the notification procedure in Article 17 of the Review Regulation by 30 October 2015. The EU Commission are in the process of preparing a non-approval decision for those active substances that have not been supported through this withdrawal notice, and ECHA should update their table once this is available, so you should check the ECHA database periodically to see if your product would have to be removed from the market due to a non-approval decision for an active substance it contains.

European Chemicals Agency Open Invitations

The EU Commission no longer publish withdrawal notices. Instead the European Chemicals Agency (ECHA) publishes Open Invitations on their website. These open invitation allow anyone to support active substance/product type combinations where:

• all participants have withdrawn their support; or
• the active substance has been redefined; or
• a declaration of interest has been accepted.

Anyone wishing to take over the role of participant of an active substance/product type combination listed in an ECHA Open Invitation has to complete the notification procedure in Article 17 of the Review Regulation by the deadline listed in the Open Invitation.

The entry on ECHA’s upcoming deadlines webpage will provide the reason why the active substance/product type combination listed is eligible for inclusion in the review programme and also the deadline for completing the notification procedure in Article 17 of the Review Regulation.

The ECHA website provides further details on how to complete the notification procedure in Article 17 of the Review Regulation.

If the approval date for the relevant product type for all the active substances in your product has already passed you will have to apply for and receive product authorisation before the biocidal can be placed on the UK market.

If the approval date for one or more active substances is in the future then you need to apply for product authorisation by the approval date for the last active substance. Until the date of approval of the last active substance the biocidal product must comply where necessary with the requirements of relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR. See our Existing UK National Legislation page for more information.

If all the active substances are listed in Annex I you must apply for and receive simplified product authorisation before the biocidal product can be made available on the UK market.

If you have received simplified authorisation in another EU Member State and you intend to place the biocidal product on the UK market you must notify HSE via R4BP at least 30 days before placing the biocidal product on the UK market.

If all the active substances are under review for the relevant product type you can make the biocidal product available in the UK, complying where necessary with the requirements of relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR. See our Existing UK National Legislation page for more information.

If one or more the active substances are under review for the relevant product type you can make the biocidal product available in the UK, complying where necessary with the requirements of relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR. See our Existing UK National Legislation page for more information.

When the last active substance is approved you will need to apply for product authorisation by the approval date for the last active substance.

As all the active substances are not in Annex I to the EU BPR you have to apply for and receive product authorisation (rather than simplified product authorisation) before the biocidal can be placed on the UK market.

If one or more the active substances are under review for the relevant product type you can make the biocidal product available in the UK, complying where necessary with the requirements of relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR. See our Existing UK National Legislation page for more information.

When the last review active substance is approved you will need to apply for product authorisation (rather than simplified product authorisation) by the approval date for the last active substance.

If you find that the active substance, in the relevant product type, is listed in Part 2 of Annex II of the EU BPR Review Regulation ((page 28 to page 33) (i.e. it is subject to withdrawal) but not in a non-approval decision please contact us as this may mean a decision is working through the EU legal process.

If one or more active substances in the product, is listed in a European Chemicals Agency Open Invitation in the relevant product type any one can comes forward to take over support of that substance by relevant deadline.

Until the deadline list you could make the biocidal product available in the UK complying where necessary with the requirements of relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR. See our Existing UK National Legislation page for more information.

If you find that the active substance, in the relevant product type, is listed in an Open Invitation and the deadline for support it has passed please contact us as this may mean a decision is working through the EU legal process.

If the active substance is listed in a non-approval decision, in the relevant product type, you can’t use it as an active substance in biocidal products made available on the EU market after the date referred to Article 89 of the EU BPR. This will normally be:

• 12 months from the date of the decision for making the product available; and
• 18 months from the date of the decision for its use.

NOTE: The 12 months period for making the product available on the market relates to all making available of the biocidal product 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). Therefore once the 12 month period has expired there should be no supply of an affected product anywhere in that supply chain.

Where a product has more than one active substance, for example one or more still under review or Approved and one or more subject to a non-approval decision, then the product will still have to be removed from the market and from use to the deadlines referred to in the non-approval decision.

If you decide to make the biocidal product available during the phase out period you will need to comply where necessary with the requirements of relevant national legislation, such as the Control of Pesticides Regulations (COPR) in the UK, and also to the specific elements of EU BPR. See our Existing UK National Legislation page for more information.