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In-situ generation

This page provides information on the provisions, including transitional measures, for in-situ generated active substances under the EU Biocides Regulation 528/2012 (EU BPR). Please note the information below is HSE’s current view of the requirements; this could be subject to change if further guidance is published at the European level.

Introduction

The provisions for in-situ generated active substances only apply to biocides that are generated at the point of use. The provisions do not apply to biocides generated via an in-situ process that are then made available on the market for supply and then subsequent use e.g. biocides generated and then bottled up and supplied on to a third party.

Background

Biocidal Products Directive 98/8/EC

The Biocidal Products Directive 98/8/EC (BPD) didn’t specifically cover in-situ generation in the definition of a biocidal product. However, it was agreed at the EU level that where there was the supply of one or more precursors, with the intention that they were to be used to generate a biocide in-situ, these precursors were biocidal products and the BPD applied.

However under the BPD it was not clear what should have been notified for review under the biocides Review Programme; the substance generated in-situ, the precursor(s) or a combination of the two. Therefore a mixture of the above was notified with no co-ordinated approach.

Where an in-situ generated biocide

the generated active substance (and the general chemical supplied)was not within the scope of the BPD and was not regulated.

EU Biocides Regulation 528/2012

The EU Biocides Regulation 528/2012 (EU BPR) repealed and replaced the BPD on 1 September 2013 and the position for in-situ biocides is clarified.

Under the EU BPR the definition of a biocidal product is

The supply of a precursor with the intention that it is to be used to generate a biocide in-situ falls under the first indent of the definition of a biocidal product under the EU BPR.

Biocides generated in-situ from ambient precursors that are not supplied (e.g. air, seawater) and generated in-situ from general chemicals fall under the second indent of the definition of a biocidal product under the EU BPR.

All in-situ generation of biocides is within scope of the EU BPR.

What is the biocidal product?

The biocidal product which requires authorisation before it is supplied or used (once the active substance is approved) will be either:

For example, if active chlorine is generated from sodium chloride, which is intentionally supplied for purpose, the sodium chloride is the biocidal product.

If active chloride is generated from sea water, the active chloride is the biocidal product. In this situation active chloride is the active substance and the biocidal product, as there is no supply of sea water with the intention it is used for this purpose.

Do in-situ generation machines require authorisation?

The UK view is that an in-situ generation machine doesn’t meet the definition of a biocidal product as it is not a substance or mixture; therefore the machine itself would not require authorisation. However, as part of the product authorisation process the machine used to generate the active substance may be considered and the conditions of product authorisation may stipulate the use of a specific machine.

More information on the product authorisation process for in-situ generation will be published as and when it is available.

Transitional Provisions

Several in situ generated active substances/precursor/product type combinations are not supported under the biocides Review Programme or are supported for different product-types than the ones for which they are used.

To find out what combinations are made available or used on the EU market, the EU Commission consulted stakeholders in 2014. Based on the information received, the EU Commission compiled a list of all known precursor(s)/active substance(s)/product type combinations that are currently made available or used on the EU market, see EU Commission CA paper "substance generated in situ" (CA-March15-Doc.5.1-Final.

This list enabled the EU Commission to define:

Please note the list provided in EU Commission CA paper is not an exhaustive list of the active substance/precursor(s)/product type combination(s) that could be eligible for inclusion in the biocides Review Programme.

For information on supporting precursor(s)/active substance(s)/product type(s) combinations under Article 93 of EU BPR or Article 13 of the biocides Review Regulation see the relevant section below.

Article 93 of the EU BPR

Article 93 of the EU BPR outlines transitional provisions for biocides that weren’t regulated under the BPD but are now regulated under the EU BPR. These transitional provisions apply to biocides generated in-situ from ambient precursors (e.g. air, seawater) and generated in-situ from general chemicals where they were not supplied with the intention that they were to be used to generate biocidal active substances.

If the precursor(s)/active substance(s)/product type(s) combination has not already been supported in the relevant product type under biocides review programme, then companies may submit applications for approval of the precursor(s)/active substance(s)/product type(s) combination by 1 September 2016.

If an appropriate application is made by 1 September 2016 the precursor(s)/active substance(s)/product type(s) combination can continue to be used until a decision on approval for precursor(s)/active substance(s)/product type(s) combination.

If no application for approval of precursor(s)/active substance(s)/product type(s) combination is submitted, then that precursor(s)/active substance(s)/product type(s) combination can no longer be used after 1st September 2017.

Please note existing National Legislation in each Member State will continue to apply to the precursor(s)/active substance(s)/product type(s) combination. You will need to contact each EU Member State for details of their existing National Legislation. For the UK, details can be found on the UK existing National Legislation section of this website. 

What information has to be included in my application?

An application for approval of an active substance must contain data to meet the information requirements as outlined in Annex II and Annex III to the EU BPR. Information on the precursor(s) and the generated active substance(s) must be submitted.

Where there isn’t an evaluating competent authority listed in the EU Commission CA paper (substance generated in situ" (CA-March15-Doc.5.1-Final ) for the precursor(s)/active substance(s)/product type(s) combination the applicant should include the details of the competent authority they would like to evaluate their dossier and provide evidence that the competent authority agrees to do so.

The ECHA website contains various guidance documents to explain the information requirements outlined in Annex II and Annex III to the EU BPR.

ECHA’s Biocides Submission Manuals describe how to build IUCLID dossiers for the various applications under the EU BPR and how to submit and manage those applications in R4BP.

How do I submit my application?

An application has to be submitted using ECHA’s R4BP system with the data in the IUCLID format.

ECHA’s Biocides Submission Manuals describe how to build IUCLID dossiers for the various applications under the EU BPR and how to submit and manage those applications in R4BP.

What fees do I have to pay?

ECHA and the evaluating competent authority will charge a fee to manage and evaluate the application. Further information on ECHA’s fees can be found in their Fee Regulation (EU) No 564/2013. For further information about ECHA or Member States fees please contact ECHA  or each EU Member State. Details of the fee’s charge in the UK can be found in our biocides fees section.

Redefining under Article 13 of biocides Review Regulation (Regulation EU No. 1062/2014)

Under the BPD the in situ generated active substances supported under the biocides review programme were not consistently specified in the BPD Fifth Review Regulation (EU Regulation No. 1451/2007) and only some of the several possible precursors have been supported for review.

Under the EU BPR both the precursor(s) and the substances they generate will be specified and systematically evaluated.

The current review programme of active substances therefore may not refer to all precursors/in situ generated active substances combinations. Where the precursor(s)/active substance(s) combination(s) have been redefined to clarify those combinations that are considered to be currently included in the review programme, any additional precursor/active substance combinations that have been identified are now being made available for industry to support for review.

The European Chemicals Agency (ECHA) Open Invitation

ECHA published an Open Invitation to allow companies to submit a notification, under Article 13 of the Review Regulation, via R4BP by 27 April 2016 to have the relevant precursor(s)/active substance/product type combinations included in the biocides review programme. The Open Invitation includes a table and the precursor(s)/active substance/product type combinations eligible for Notification can be found in the fourth column; please note this is not an exhaustive list but Notifications are only possible for precursor(s)/active substance/product type combinations not already covered by the new identity.

How do I submit a notification?

The notification must be submitted via R4BP. Guidance on submitting a Notification can be found on ECHA’s website.  Please note R4BP is an ECHA IT system and questions/queries on using the system should be directed to ECHA not HSE.

What information does the Notification need to contain?

The R4BP notification must contain the following information in the IUCLID format;

  • evidence that the substance is an existing active substance within the meaning of Article 3(1)(d) of EU BPR i.e. the substance’ were on the market on 14 May 2000 as an active substance in a biocidal product;
  • an indication of the product-type(s) concerned by the notification;
  • information on any studies that have been commissioned for the purpose of application for Approval under EU BPR or for inclusion in Annex I to EU BPR, as well as the expected date of completion;
  • the information referred to in Sections
    • 1, 2 and 7.1 to 7.5 of the table in Title 1 of Annex II to EU BPR for chemical substances;
    • 1, 2 and 6.1 to 6.4 of the table in Title 2 of Annex II to EU BPR for micro-organisms;

Where there isn’t an evaluating competent authority listed in the EU Commission CA paper (substance generated in situ" (CA-March15-Doc.5.1-Final ) for the precursor(s)/active substance(s)/product type(s) combination (e.g. active substance isn’t listed as being evaluated by a competent authority for a different product type) the applicant should include the details of the competent authority they would like to evaluate their dossier and provide evidence that the competent authority agrees to do so.

What fees do I have to pay?

The notification process is managed by ECHA. The UK understands that ECHA charges a fee of 10,000 Euros per notification of a substance/product-type(s) combination. This fee will be deducted from the application fee for approval of the active substance/product-type combination. Further information on ECHA’s fees can be found in their Fee Regulation (EU) No 564/2013. For further information about ECHA fees please contact them, not HSE.

What happens if ECHA accepts the notification?

If the notification is accepted by ECHA, companies have two years to submit a full application for active substance approval. The evaluation process and timelines for the evaluation of these precursor(s)/active substance/product type combinations can be found in Article 3 to 9 of the Review Regulation. Until a decision on approval is taken, the precursor/active substance/product type combination can be made available on the market and used.

Please note existing National Legislation in each Member State will continue to apply to the precursor(s)/active substance(s)/product type(s) combination. You will need to contact each EU Member State for details of their existing National Legislation. For the UK, details can be found on the UK existing National Legislation section of this website.

When does the full dossier for the precursor(s)/active substance/product type combinations need to be submitted?

The full dossier for the precursor(s)/active substance/product type combination(s) needs to be submitted within two years of ECHA declaring that they have accepted the Notification to include the precursor(s)/active substance/product type combinations into the biocides review programme.

When will the precursor(s)/active substance/product type combination be approved?

The evaluation process and timelines for the evaluation of these precursor(s)/active substance/product type combinations can be found in Article 3 to 9 of the Review Regulation. Until a decision on approval is taken, the precursor/active substance/product type combination can be made available on the market and used.
Please note existing National Legislation in each Member State will continue to apply to the precursor(s)/active substance(s)/product type(s) combination. You will need to contact each EU Member State for details of their existing National Legislation. For the UK, details can be found on the UK existing National Legislation section of this website. 

What happens if nobody notifies or ECHA rejects the notification?

If your precursor(s)/active substance/product type combinations is on the list of new combinations published by ECHA, but nobody notifies by 27 April 2016 or ECHA rejects a notification that has been made, the precursor(s)/active substance(s)/product type(s) combination cannot be made available or used.

Article 95

The objective of the Article 95 requirements of the EU BPR is to ensure that the costs of generating data and supporting active substances are shared fairly.
When the requirements of Article 95 apply to in-situ generated biocides depends on

If the precursor(s) is made available on the EU market with a biocidal intention/claim and where the precursor(s)/active substance(s)/product type(s) combination is currently included in the review programme the requirements of Article 95 will apply from 1 September 2015.

If the precursor(s) is made available on the EU market with a biocidal intention/claim and where the precursor(s)/active substance(s)/product type(s) has been redefined under Article 13 of the biocides Review Regulation the requirements of Article 95 will apply once a dossier has been submitted for review, validated as complete and subsequently included in the Article 95 list.

If the precursor is not made available on the EU market with a biocidal intention/claim the requirements of Article 95 of the EU BPR will not apply, e.g. general chemical or ambient substance is used as the precursor. This is because the precursor(s)/active substance(s)/product type(s) combination is not made available on the EU market for biocides purposes. In addition the prohibition in Article 95 does not prohibit use only making available on the market.

For example the Article 95 compliance deadlines for active chlorine will be

 

Updated 2016-02-08