Sonntag, 13. September 2015

0009-Insitu Products- Chlorine-Chlorine Dioxide-ECHA- Regulation 528-Revised on 23 June 2015

CA-March15-Doc.5.1-Final
Revised on 23 June 2015



59th meeting of representatives of Members States Competent Authorities for the implementation of Regulation 528/2012 concerning the making available on the market and use of biocidal products


Management of in situ generated active substances in the context of the BPR

1.          Purpose of the document

This document provides details of the management of in situ generated active substances under Regulation (EU) No 528/2012 as agreed at the 59th CA meeting.

2.          background

At the 52nd CA meeting, the Commission presented a paper CA-July13-Doc.5.1.l proposing a Way forward on the management of in situ generated active substances in the context of the BPR.
During the discussions of that paper, it was pointed out that the proposed approach could lead to a substantial increase to the number of active substance /product-type combinations to be examined under the review programme. It was therefore agreed to gather more information with a view to have an informed discussion concerning the impact of the different policy options.
Against that background, the Commission initiated a wide consultation of stakeholders to identify the combination of precursors/active substances currently made available or used on the EU market. More than 300 contributions were received.
After several consultations and a workshop held on 15 October 2014 with participation of Member States and stakeholders, it was concluded that it would be better to consider as many precursors as possible at the substance approval stage, despite the potential workload implied, with a view however to make the product authorisation process more efficient afterwards.
The analysis however confirms the initial concern that such an approach would entail a significant number of re-submissions. On some substances, it seems nevertheless possible to perform an assessment that could cover various precursors at the same time. Therefore, a compromised approached was agreed for certain substances, such as chlorine dioxide.
From that analysis, it also appears that some of the precursors/active substances combinations currently placed on the market were not supported under the review programme (e.g. monochloramine), or are supported for different product-types than the ones for which they are used.

3.          way forward

Section 3.1 addresses the situation of in situ generated active substances, whilst section 3.2 brings clarification regarding active substance releasers, as these should be clearly distinguished from in situ generated active substances. Lastly, the case of specific substances such as ozone, nitrogen or hydroxylradicals remains to be addressed.

3.1.        Substances generated in situ

In situ generated active substances can be defined as substances, which are generated at the place of use from one or more precursors.
Review programme
All applications under evaluation in the review programme include a dossier on the active substance and a dossier on a representative biocidal product, which for in situ generated active substances will be the precursor(s).
For all substances generated in situ, the active substance shall be defined by reference to the precursor(s) supported in the dossier under evaluation and to the substance generated.
This may in certain cases lead to a re-definition of the substance, as originally notified, and/or to the creation of additional entries, when data on several precursors were provided in a dossier, or when multiple dossiers have been submitted for a substance (e.g. chlorine dioxide to be redefined as Chlorine dioxide generated from sodium chlorite by electrolysis and as chlorine dioxide generated from sodium chlorate and hydrogen peroxide in the presence of a strong acid)[1].
For those substances to be redefined, Article 13, 14 and 17 of Regulation (EU) No 1062/2014[2] (hereafter referred as the Review Programme Regulation) shall apply and persons affected by the substance re-definition shall be given the possibility to take over the role of participant[3].
Upon receiving information from ECHA that notifications to take over the role of participant have been found compliant, the Commission will amend part 1 of Annex II of the Review Programme Regulation so that in situ generated active substances are described as indicated in Annex I of this document.
Substance approval
At the time of the substance approval, the Commission implementing Regulation would then refer to the precursor(s) supported in the dossier and to the active substance that will be generated from this(ese) precursor(s), including when relevant the generation method.
Article 95
Likewise, the list published by ECHA shall be updated and in situ generated active substances supported under the review programme shall be described as indicated in Annex I of this document.
Current participants in the review programme will be listed as substance/product suppliers.
Other companies will be added to the list provided they submit their own dossier, or an LoA to such a dossier.
In the case of in situ generated active substances, the dossier or LoA will need to cover data on both the in situ generated active substance and the precursor(s), which form the representative product, supported in the dossier under evaluation.
Suppliers of substances to be used as precursors for the in situ generation of active substances included in the review programme have to submit to ECHA their own dossier on the precursor(s) and the in situ generated active substance, or a letter of access to such a dossier, in so far as the precursor(s) placed on the market and the active substance generated from this(ese) precursor(s) are the same  as the ones supported under the review programme[4].  These suppliers will have to be listed by 1 September 2015.
It is to be noted though that, as Article 95(2) refers to biocidal products, substances made available on the market without any indication (e.g. butane in the form of gas canisters) that they can be used as precursors for the in situ generation of an active substance would not be covered, although they might be used for that purpose. Such substances could therefore still be used during the transitional period provided for under Article 93 of the BPR. However, beyond this transitional period, such a use of a substance will be considered as use of a biocidal product and would not be allowed unless that biocidal product is authorised.
In addition, the additional precursor(s)/active substance combinations listed in the fourth column of Annex I would initially not be included in the Article 95 list (as no “complete substance dossier” according to Article 95(1) would have been submitted). Consequently, the deadline of 1 September 2015 does not apply to suppliers of these additional precursor(s)/active substance combinations. However, as soon as a “complete substance dossier” has been submitted under Article 13 of the Review Programme Regulation or Article 93 of the BPR and accepted, the substance would be included in the Article 95 list and consequently Article 95(2) would apply.


Technical equivalence
It is acknowledged that a comparison of the chemical composition and hazard profile of the in situ generated active substances would be technically difficult, if not impossible, to achieve, as it may in particular be challenging to establish a reference source.
It might however be possible to establish technical specifications or to refer to existing standards, such as CEN standards. These technical specifications could be established either for the active substance itself or its precursors, as appropriate, at the time of the substance approval.
It will then have to be ensured and demonstrated at the time of product authorisation that the precursors or the active substances, as appropriate, meet the agreed specifications.
Finally, when an in situ generated active substance may also be placed on the market itself (e.g. peracetic acid), specifications would still have to be established in order to allow the establishment of technical equivalence in those cases where the active substance itself is placed on the market.
Article 93
Several in situ generated active substances are either not supported under the review programme or are supported for different product-types than the ones for which they are used.
Those in situ generated active substances will therefore not be able to benefit from the provisions of Article 13 of the Review Programme Regulation, which can only cover what was already within the scope of the BPD.
They could however benefit from the provisions of Article 93 as precursors for the in situ generation of active substances were not considered to be in the scope of the Directive in so far as no claim was made that these precursors could be used for a biocidal purpose.[5]
Article 13 of the Review Programme Regulation vs. Article 93 of the BPR
For some in situ generated active substances, submissions of applications could be done for some product-types on the basis of Article 13 of the Review Programme Regulation, for others on the basis of Article 93 of the BPR.
This would happen in cases where the re-defined precursor(s)/active substance combination is supported under the review programme for greater number of product-types than those in use for the precursor(s)/active substance, for which the role of participant is to be taken over (see for instance active chlorine).
In such cases, for the sake of simplification, the applicant may decide to group all product-types together and use only one application route (i.e. Article 13 of the Review Programme Regulation or Article 93 of the BPR).


Consortium
Specific precursor(s)/active substance combinations may be supported individually. This does however not rule out that a consortium could be set up to support different generation systems through the same application. This could be of interest for monochloramine, peracetic acid or active bromine.
Biocidal products
For in situ generated active substances, the biocidal product which is subject to authorisation before it can be supplied or used is either:
- the substance(s) or mixture(s) generating the active substance; or
- the active substance generated from substances or mixtures, which cannot themselves be authorised as biocidal products.[6]

3.2.        Active substance releasers

Active substance releasers are substances which upon use release a substance, which has a biocidal activity. For such substances, no other precursor is required, the reaction is taking place under certain conditions and not necessarily at the place of use.
The substance released and the substance releaser shall be regarded as the active substance and be managed as such.
Furthermore, the name of the active substance will be the combination of the names of the substance released and of the substance releaser (e.g. Formaldehyde released from N,N'-methylenebismorpholine).
This name will be used for the substance approval as well as for the purpose of Article 95 listing.
Technical equivalence
The requirement to proof technical equivalence at product authorisation applies to biocidal products containing active substance releasers.
Technical equivalence shall confirm the similarity, as regards the chemical composition and hazard profile, of the active substance releasers being compared.
Article 95
The list will refer to the name of the active substance releaser and the substance released.
Current participants in the review programme will thus be listed under the combination of the active substance releaser and the substance released.
Other companies will be added to the list provided they have their own dossier on the active substance, or a letter of access to such a dossier.


4.          Conclusion

The principles of this note were endorsed at the 58th CA meeting and the annexes finalised at the 59th CA meeting after a final consultation between the Commission services, the evaluating competent authorities and the participants concerned.
In accordance with Article 14 of Regulation (EU) No 1062/2014, the European Chemicals Agency will now publish an open invitation to take over the role of participant for those substance/precursor/product-type combinations, which have been the subject of a redefinition, as described in Article 13 of that Regulation.
Furthermore, it shall be noted that the list of substances described in the fourth column of the tables in Annex I and II is not exhaustive and that there might be other active substance/precursor/product-type combinations placed on the market, which might be eligible for a taking over pursuant to Article 14 of Regulation (EU) No 1062/2014 or for which applications can be submitted pursuant to Article 93 of the BPR.
However, for new systems (i.e. active substance/precursor/product-type combinations which were not made available on the market on 1 September 2013), the active substance will need to be approved and the biocidal product authorised before such new systems can be made available on the market.
Finally, for the purpose of product authorisation, it shall be recalled again that any company can be authorisation holder. It may thus be either the company supplying the precursors, the company manufacturing the devices in which these precursors will be used, or the company using the device with a view to generate the active substance.




[1] Further details of the proposed re-definitions are provided in Annex I (in column 3 of the tables).
[2] Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance ) OJ L 294, 10.10.2014, p. 1–34
[3] Further details on the process are provided in Annex III.
[4] These are listed in the third column of Annex I of this document.
[5] Those precursor/active substance combinations which could benefit from the provisions of Article 93 of the BPR are listed in the last column of the tables provided in Annex I.
[6] This would apply to ozone generated from ambient air, active chlorine generated from sea water.

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