Sonntag, 13. September 2015

0008-In situ generated active substances-Active substances and suppliers

http://echa.europa.eu/de/regulations/biocidal-products-regulation/in-situ-generated-active-substances

In situ generated active substances
abgerufen : 2015-09-13
Biocidal active substances are called in situ generated active substances if they are generated from one or more precursors at the place of use. The approval of such substance requires evaluation of the generated active substance and of the precursor(s) it is generated from, in the context of each product type(PT). Some examples of these combinations are:
·         Active chlorine generated from sodium chloride by electrolysis;
·         Active chlorine generated from potassium chloride by electrolysis;
·         Active bromine generated from sodium bromide and sodium hypochlorite;
·         Hydrogen peroxide generated from sodium percarbonate by dissolution in water.
While many in situ generated active substances are included in the Review Programme, the submission of data on the precursors has not been consistent (e.g. data on several precursors were provided in a single dossier), and consequently precursors have not been consistently evaluated.
The European Commission prepared a proposal that aims at defining the in situ generated active substances currently in the review programme by reference to the precursor(s) supported in the dossier under evaluation and to the substance generated. As a result, addition combinations have been introduced to ensure that all the combinations currently placed on the market are adequately evaluated. This proposal was discussed and endorsed by the Member States at their 58th meeting on 12-14 November 2014.
The Commission proposal therefore contains a list of precursor(s)/active substance/PT combinations known to be made available or used on the EU market. Some of the combinations are already supported in the Review Programme but others are not. To keep their biocidal products on the market companies will in some cases need to take action as further explained below.
What will happen next with the in situ generated substances? 
·         ECHA will publish in its website the finalised Commission list. The list will contain the combinations not currently supported in the Review Programme. If companies wish to take over the role of a participant under the review programme for these combinations they need to make a notification, and subsequently submit an application. 
·         Some combinations are not eligible for inclusion in the Review Programme (because the active substance was not originally notified, or because the combination is only supported for other PTs) but companies will have the possibility to benefit from the transitional provision of Article 93 of the BPR and submit an application for the approval of the in situ generated active substance. If this submission is done before 1 September 2016 the product, i.e. the precursor(s) generating the active substance, can be maintained on the market.
·         If a precursor(s)/active substance combination is relevant for more product types (PTs) with some of them falling under the first application route (i.e. taking over the role of a participant under the review programme) while others under the second (Article 93), applicants can decide to apply for the approval of all the combinations through a single submission choosing one of the two application routes. 
Do I need to make an application for Article 95 for an in situ generated active substance and its precursor? 
Combinations not currently in the Review Programme: The list published by the Agency under Article 95 of the BPR, is a list of "relevant substances". A substance is only "relevant" when the complete substance dossier has been submitted and accepted or validated by a Member State under the BPR or the BPD (Directive 98/8/EC).
Therefore, once the application for the active substance approval, which shall include the information required by Annex II or, for dossiers submitted under the BPD the information required by Annex IIA or IVA and where relevant IIIA, has been accepted or validated by the Member State, the applicant will be included in the Article 95 list for the precursor(s)/active substance/PT combination.
However, where the application has not yet been validated, the substance is not "relevant" and the requirement to comply with Article 95(2) i.e. the obligation for a supplier to be on the list for products to be made available after 1 September 2015, does not apply. In practice, this means that for the additional precursor(s)/active substance/product type (PT) combinations that are introduced as a result of the redefinition of the in situ generated active substances currently in the review programme the deadline of 1 September 2015 will not apply, and the obligations under Article 95 will only apply at a later date i.e. when the approval application is validated.
Combinations already in the Review Programme: The 1 September 2015 deadline applies for combinations currently in the Review Programme. The current entries will be renamed on the Article 95 list to clearly indicate both the active substance and its precursor(s).
Where a combination is there, the alternative supplier of that combination will need to apply to be on the list and be listed by 1 September 2015. 
Active substances and suppliers
The Biocidal Products Regulation (BPR) aims to make sure that the costs of the data on active substances are fairly shared.
Companies that have not already submitted their own dossier on an active substance under the Biocidal Products Directive (BPD) or the BPR can either submit a dossier, a letter of access, or if all data protection periods have expired, a reference to an existing dossier to ECHA. This information must comply with the data requirements for active substances of the BPR or the BPD.
Applications for inclusion in the list of active substances suppliers (Article 95 list) can only be made by a person established within the EU. The definitions of substance supplier and product supplier, as set out in Article 95(1), second sub-paragraph, specify that those entities must be established in the EU. However, non-EU companies can be represented by an EU representative, for the purpose of Article 95, and be indicated on the list next to their EU representative.
In addition to manufacturers and importers, the amendment of the BPR introduced by Regulation (EU) No 334/2014 on 11 March 2014 also allows product suppliers (e.g. formulators) to apply to be included in the Article 95 list. The amendment requires that the list also specifies the product type (PT) for which an application has been made.
ECHA will publish and regularly update the Article 95 list to include those entities who have made a successful submission of the required information (see link to the Article 95 list).
From 1 September 2015, a biocidal product consisting of, containing, or generating a relevant substance, cannot be made available on the EU market if the substance supplier or product supplier is not included in the list for the product type to which the product belongs.
In the context of the Article 95 list, and limited to active substances in the review programme, the principle of mandatory data sharing applies not only to tests involving vertebrate animals but also to all toxicological, ecotoxicological and environmental fate and behaviour studies, including any such studies not involving tests on vertebrates. This implies that applicants must share and not duplicate studies and tests on vertebrate animals, which should be undertaken as a last resort.
Any substance or product supplier intending to perform tests or studies may, in the case of non-vertebrate animal tests, and must, in the case of vertebrate animal tests, inquire with the Agency whether such tests or studies have already been submitted to any competent authority or to the Agency under the BPD or the BPR.
The Agency will provide the prospective applicant with the contact details of the relevant data submitter. This inquiry step is a pre-condition before any data sharing dispute can be brought before the Agency because the relevant timelines for the dispute procedure are calculated from the date on which the Agency provides the contact details of the data submitter.

http://echa.europa.eu/documents/10162/17287015/biocides_substances_redefined_identity_en.pdf

https://echa.europa.eu/documents/10162/17287015/appoval_active_substances_etter_in_situ_en.pdf

http://www.cefic.org/About-us/How-Cefic-is-organised/Fine-Speciality-and-Consumer-Chemicals/Sodium-Chlorite-BPD-Registration-Group/


Sodium Chlorite BPD Registration Group (BPD RG)



Uses and properties

Sodium chlorite is used as a reservoir to generate solutions of chlorine dioxide. Chlorine dioxide may be used for various applications including the disinfection of surfaces in private and public health area as well as in veterinary hygiene area, the purification of drinking water, bleaching textiles and disinfecting food and waste water. In all these applications, the product has a selective effectiveness which improves its environmental performance.

Inclusion of chlorine dioxide generated in situ from sodium chlorite in the European Biocides Scheme (Biocidal Products Regulation (EU/528/2012)

The Biocidal Products Regulation (BPR) (EU/528/2012) was adopted in 2012 and came into effect on 1st September 2013. The BPR aims to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, while ensuring a high level of protection of both human and animal health and the environment. 
The BPR replaced the Biocidal Products Directive (BPD) 98/8/EC previously in force since 2000. More information on the BPR is available on the European Chemicals Agency (ECHA) website
The members of the Sodium Chlorite BPD Registration Group support the approval of chlorine dioxide generated in situ from sodium chlorite as an active substance under the BPR.
Members
Supporting documents

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