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/
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
- Bio-Cide International, Inc. (as represented in the EU by Tristel Solutions Limited)
- Caffaro Brescia S.r.l.
- Ercros, SA
Supporting documents
- Status of the sodium chlorite dossier under the European Biocides Scheme
- Information for manufacturers and importers (suppliers) of sodium chlorite as a biocidal active substance in view of compliance with Article 95 of the BPR
- Information for product authorisation purposes under the BPR
- Information for product authorisation purposes under the transitional period in national schemes
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