Zulassungen, Anträge, Adressen usw. in UNGARN

https://www.antsz.hu/en/biocide/transitional_period

Transitional Period

2012.02.01. 

According to the Directive 98/8/EC until the inclusion of the active substance (transitional period) the placing on the market of the biocidal products are regulated by the national regulations in force.

To see the details of the Hungarian regulations in force please click below on the product type of your interest.

Zulassungen, Anträge, Adressen usw. in UNGARN

Product type 1: Human hygiene biocidal products
Products in this group are biocidal products used for human hygiene purposes.

Product type 2: Private area and public health area disinfectants and other biocidal productsa.) Private area and public health area and disinfectants and other biocidal products 
b.) Products used for the disinfection of swimming pools, aquariums, bathing and other waters

Products used for the disinfection of air, surfaces, materials, equipment and furniture which are not used for direct food or feed contact in private, public and industrial areas, including hospitals, as well as products used as algaecides.
Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air-conditioning systems; walls and floors in health and other institutions; chemical toilets, waste water, hospital waste, soil or other substrates (in playgrounds).

Product type 3: Veterinary hygiene biocidal products a.) Surface or airspace disinfectant products for veterinary purposes 
b.) Veterinary hygiene biocidal products

Products in this group are biocidal products used for veterinary hygiene purposes including products used in areas in which animals are housed, kept or transported.

Product type 4: Food and feed area disinfectants
Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food, feed or drink (including drinking water) for humans and animals.

Product type 5: Drinking water disinfectants
Products used for the disinfection of drinking water (for both humans and animals).

Product type 6: In-can preservatives
Products used for the preservation of manufactured products, other than foodstuffs or feedingstuffs, in containers by the control of microbial deterioration to ensure their shelf life.

Product type 7: Film preservatives
Products used for the preservation of films or coatings by the control of microbial deterioration in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works.

Product type 8: Wood preservatives
Products used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms.
This product type includes both preventive and curative products.

Product type 9: Fibre, leather, rubber and polymerised materials preservatives
Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products and rubber by the control of microbiological deterioration.

Product type 10: Masonry preservatives
Products used for preservation and remedial treatment of masonry or other construction materials other than wood by the control of microbiological and algal attack.

Product type 11: Preservatives for liquid-cooling and processing systems
Products used for the preservation of water or other liquids used in cooling and processing systems by the control of harmful organisms such as microbes, algae and mussels.
Products used for the preservation of drinking water are not included in this product type.

Product type 12: Slimicides 
Products used for the prevention or control of slime growth on materials, equipment and structures, used in industrial processes, e.g. on wood and paper pulp, porous sand strata in oil extraction.

Product type 13: Metalworking-fluid preservatives
Products used for the preservation of metalworking fluids by the control of microbial deterioration.

Product type 14: Rodenticides a.) Products used against health pests 
b.) Products used against non-health pests 
Products used for the control of mice, rats or other rodents.

Product type 15: Avicides 
Products used for the control of birds.

Product type 16: Molluscicides 
Products used for the control of molluscs.

Product type 17: Piscicides 
Products used for the control of fish; these products exclude products for the treatment of fish diseases.

Product type 18: Insecticides, acaricides and products to control other arthropods a.) Products used against health pests 
b.) Products used for animal purposes 
c.) Products used for other purposes 
Products used for the control of arthropods (e.g. insects, arachnids and crustaceans).

Product type 19: Repellents and attractants a.) Products used against health pests 
b.) Products used for animal purposes 
c.) Products used for other purposes 
Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds), by repelling or attracting, including those that are used for human or veterinary hygiene either directly or indirectly.

Product type 20: Preservatives for food or feedstocks
Products used for the preservation of food or feedstocks by the control of harmful organisms.

Product type 21: Antifouling products
Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water.

Product type 22: Embalming and taxidermist fluids
Products used for the disinfection and preservation of human or animal corpses, or parts thereof.

Product type 23: Control of other vertebrates
Products used for the control of vermin.

TwinOxide-Video

http://www.twinoxide.com/video-2/

National helpdesks contact details

http://echa.europa.eu/web/guest/support/helpdesks/national-helpdesks/list-of-national-helpdesks

National helpdesks contact details

Austria

Belgium

Bulgaria

Croatia

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Iceland

Ireland

Italy

Latvia

Liechtenstein

Lithuania

Luxembourg

Malta

Netherlands

Norway

Poland

Portugal

Romania

Slovakia

Slovenia

Spain

Sweden

United Kingdom

Notification procedure

http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance/notification-procedure

Notification procedure

 

The notification process to take over the role of participant or to include an active substance/product-type in the Review Programme has the following steps:

 

A notifier (prospective participant) submits a notification in a IUCLID file through R4BP 3 containing the information listed in Annex I of the Review Programme Regulation

 

ECHA accepts the application and informs the notifier who has 30 days to pay the applicable fees.

The notifier pays the related fees to ECHA within 30 days. In case payment is not made within the deadline, the notification will be rejected.

 

Upon receipt of the fee payment, ECHA verifies within 30 days that the notification has been submitted in the correct format and contains the data requirements listed in Annex I of Review Programme Regulation (EU) N0 1062/2014.

 

If the notification is not compliant, ECHA will grant the notifier 30 days to correct or complete the notification.

 

ECHA declares the notification as compliant or it rejects the notification if it considers it not to be compliant.*

 

When a notification is considered compliant, the European Commission takes the decision to include the substance/product-type combination in the Review Programme.

 

Actors

The main actors in the notification process are:

• Notifiers
  The notifiers are the prospective participants. The notifiers are responsible for providing all necessary information in their notifications. They should pay attention to the various deadlines throughout the process.
• ECHA
  ECHA performs the format and compliance check of the notifications and declares it compliant or not.
• European Commission
  The European Commission takes into consideration the declaration by ECHA on the compliance of the notification and, if relevant, includes the substance/PT combination in the Review Programme.

For substance/product-type combinations which are no longer supported, in the absence of any compliant notification by the applicable deadline, or if the notification is rejected, or where the substance identity is not fully covered, the substance/product-type will be the subject of a Commission non-approval decision in accordance with Article 89(1) of the BPR.

*An appeal may be brought against an ECHA decision on the compliance of the notification in accordance with Article 77 of the BPR.

Vorhandener Wirkstoff

http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance?panel=notification-procedure#notification-procedure

Vorhandener Wirkstoff

The Review Programme is the name commonly used for the work programme for the examination of existing biocidal active substances contained in biocidal products. The programme was set up by the European Commission under the Biocidal Products Directive (BPD) and continues under the Biocidal Products Regulation (BPR).

Existing active substances are those substances which were on the market on 14 May 2000 as an active substance of a biocidal product (for purposes other than scientific or product and process-orientated research and development). The existing active substances which were accepted to be examined in the Review Programme were those which were identified as such and for which a notification was accepted, as set out in Annex II to Commission Regulation (EC) No 1451/2007.

The detailed rules for the Review Programme have been adapted to the provisions of the BPR in the new Review Programme Regulation (EU) No 1062/2014, which repeals and replaces Commission Regulation (EC) No 1451/2007.

The transitional provisions laid down in Article 89 of Regulation (EU) No 528/2012 allow biocidal products containing an active substance included in the Review Programme (for a given product-type) to be made available on the market and used, subject to national rules, until three years after the date of their approval (shorter timeframes apply in case of non-approval).

In Annex II part 1 of the Review Programme Regulation, the active substances which are under evaluation are listed.

In addition, the Review Programme Regulation adapts the processes for the evaluation of a dossier to align them to those described in the BPR for new active substances or in Regulation (EU) No 88/2014 for the amendment of Annex I.

Furthermore, the Review Programme Regulation provides a defined role for ECHA and sets out procedures on how to join or replace a participant in the Review Programme by mutual agreement, how to withdraw as a participant, how to take over the role of participant in certain situations and introduces the possibility to add substance/PT combinations to the Review Programme, under certain conditions.

The Review Programme is foreseen to be completed by 2024.

Changes of elements of the Review Programme

Change in participant for a substance/product-type combination

New combinations of substance/product-type in the Review Programme

Taking over the role of participant following substance identity redefinition

ECHA's open invitations

Notification procedure

To ensure that no substance is unduly maintained or included in the Review Programme without subsequently being evaluated, interested companies have twelve months to make a notification of essential data regarding the substance. Once the notification is declared compliant by ECHA, a participant has two yearsto submit an application.

The fee to be paid to the Agency per notification of a substance/product-type(s) combination is 10 000 Euros, according to the Fee Regulation (EU) No 564/2013. This fee will be deducted from the application fee for approval of the active substance/product-type combination.

·         Notification procedure

Application for approval or inclusion in Annex I

·         Dossier submission

·         Evaluation process

See also

·         Review Programme Regulation (EU) No 1062/2014

·         How to submit a notification in the Review Programme

Formularbeginn

Formularende

In situ generated active substances

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

In situ generated active substances

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 58^th 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.
  • Article 93 transitional measure
• 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. 

Zulassungsverfahren für Biozidprodukte mit Vorläufern für die in situ Erzeugung von Wirkstoffe

Zulassungsverfahren für Biozidprodukte mit Vorläufern für die in situ Erzeugung von Wirkstoffen

Es ist darauf hinzuweisen, dass die Vermarktung und die Verwendung von Biozidprodukten von der VBP geregelt werden. Folglich ist die Verwendung eines nicht bewilligten Produktes unzulässig.

Einleitung

Mit der neuen europäischen Verordnung über Biozidprodukte (BPR, EU Nr. 538/2012), die am 1. September 2013 in Kraft getreten ist, und der Biozidprodukteverordnung (VBP, SR 813.12) gelten in situ erzeugte Wirkstoffe sowie ihre Vorläufer als Biozide und sind zulassungspflichtig.
Das vorliegende Dokument erläutert die Lage im November 2015 und klärt die Pflichten der Firmen, die Biozide in der Schweiz vermarkten.
Gemäss BPR und VBP wird ein Wirkstoff für spezifische Anwendungen zugelassen, die als Produktarten bezeichnet werden (VBP, Anhang 10). Deshalb sprechen wir von Vorläufer/Wirkstoff/Produktart-Kombination.
Es ist wichtig anzumerken, dass alle Vorläufersubstanzen, die ohne bioziden Zweck vermarktet werden (z.B. Natriumchlorid als Regeneriersalz), nicht von dieser Regelung betroffen sind und folglich gemäss der VBP auch nicht zulassungspflichtig sind.
Überblick über die von der ECHA getroffenen Massnahmen:
Zur Klärung der Lage bei den in situ erzeugten Wirkstoffen hat die EU folgende Schritte unternommen:

• Abklärung bei den Firmen, welche in situ Anwendungen auf dem Markt sind (Vorläufer/Wirkstoff/Produktart-Kombinationen)
• Veröffentlichung einer Liste der in situ erzeugten Wirkstoffe und Anpassung der Nomenklatur der Wirkstoffe im Programm. Das Dokument kann im Internet abgerufen werden.
• Veröffentlichung einer neuen Frist zur Notifizierung der Vorläufer/Wirkstoff/Produktart-Kombinationen, die noch keiner Evaluation unterliegen. Das Dokument kann im Internet abgerufen werden. 

Siehe alle Informationen und Links im nachfolgenden Dokument:

Zulassungsverfahren für Biozidprodukte mit Vorläufern für die in situ Erzeugung von WirkstoffenGültig ab 18.12.2015 | Grösse: 355 kb | Typ: PDF

Zuletzt aktualisiert am: 18.12.2015

Notification procedure

http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance/notification-procedure

• 
  

Notification procedure

 

The notification process to take over the role of participant or to include an active substance/product-type in the Review Programme has the following steps:

 

A notifier (prospective participant) submits a notification in a IUCLID file through R4BP 3 containing the information listed in Annex I of the Review Programme Regulation

 

ECHA accepts the application and informs the notifier who has 30 days to pay the applicable fees.

The notifier pays the related fees to ECHA within 30 days. In case payment is not made within the deadline, the notification will be rejected.

 

Upon receipt of the fee payment, ECHA verifies within 30 days that the notification has been submitted in the correct format and contains the data requirements listed in Annex I of Review Programme Regulation (EU) N0 1062/2014.

 

If the notification is not compliant, ECHA will grant the notifier 30 days to correct or complete the notification.

 

ECHA declares the notification as compliant or it rejects the notification if it considers it not to be compliant.*

 

When a notification is considered compliant, the European Commission takes the decision to include the substance/product-type combination in the Review Programme.

 

Actors

The main actors in the notification process are:

• Notifiers
  The notifiers are the prospective participants. The notifiers are responsible for providing all necessary information in their notifications. They should pay attention to the various deadlines throughout the process.
• ECHA
  ECHA performs the format and compliance check of the notifications and declares it compliant or not.
• European Commission
  The European Commission takes into consideration the declaration by ECHA on the compliance of the notification and, if relevant, includes the substance/PT combination in the Review Programme.

For substance/product-type combinations which are no longer supported, in the absence of any compliant notification by the applicable deadline, or if the notification is rejected, or where the substance identity is not fully covered, the substance/product-type will be the subject of a Commission non-approval decision in accordance with Article 89(1) of the BPR.

*An appeal may be brought against an ECHA decision on the compliance of the notification in accordance with Article 77 of the BPR.