What are biocidal products?
Biocidal products are active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means Biocidal products include disinfectants used in a number of fields, chemicals used as preservatives of materials and products, pesticides for non-agricultural uses, and anti-vegetation products. An exhaustive list of 23 product types with an indicative set of descriptions within each type is given in Annex V Directive 98/8/EC and the Rules on Placing Biocidal Products on the Market (Official Gazette RS, No. 38/00, 81/03 in 114/04).
What are biocidal active substances?
A biocidal active substance can be: one chemical compound with a well-defined structure a mixture-by-process of two or more chemical compounds an UVCB-substance (substances with Unknown or Variable composition, Complex reaction products or Biological materials) microorganisms, such as bacteria, fungii, viruses extracts and oils of plants and microorganisms fermentation products of microorganisms
with a controlling effect of any harmful organism by chemical or biological means, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect.
Legislation on biocidal products overlaps with other pieces of legislation
Legislation on biocidal products borders on that of:
cosmetics, veterinary medicinal products, medicinal preparations detergents, plant protection products, others.
In border cases, i.e. when a biocidal product could be used as products subject to procedures of the above mentioned column and governed by special rules, then when deciding whether we are dealing with a biocidal product or not, we can use the definition of biocidal products and their method of use.
When it comes to deciding on border cases, EU Manual of decision for implementation of Directive 98/8/EC) is to be made full use of, not least because it consists of all cases based on practice, i.e. border products and other guidelines harmonised at Member States competent authorities level and that of the European Commission in order to implement Directive 98/8/EC.
What are (to be) procedures for placing biocidal products on the market?
Directive 98/8/EC lays down harmonised conditions under which biocidal products can be placed on the EU market. Prior to its first placement on the market, the competent authority should take a decision on whether such biocidal product should be placed on the market and under what conditions this could be done. When deciding on whether to grant authorisation for placing certain biocidal products on the market, the competent authority takes into consideration its (biocidal product) comprehensive risk assessment demonstrating that neither biocidal products nor their residues have any unacceptable impacts on human health, animals and the environment as well as on target organisms, and that such biocidal products are effective when it comes to the purpose for which they have been intended to be placed on the market.
The European Union has drafted a 10-year review programme for biocidal products containing active substances placed on the market prior to May 14th 2000, i.e. existing active substances, and according to this programme all active substances (notified active substances) with sufficient industry support will be progressively evaluated, and industry will draw up special testing documentation for them.
If active substances following their evaluation will be accepted for use in biocidal products, they will be placed on a list of substances I, IA or IB available in Annexes I, IA and IB of Directive 98/8/EC. Immediately after their inclusion on these lists, EU Member States where applicants wish to place biocidal products on the market shall draw up documentation and submit applications for authorization for biocidal products containing active substances. Provided that active substances may not be put on these lists owing to their properties established through the review of the documentation, then those biocidal products containing such active substances shall be withdrawn from the market.
Until such time that existing active substances – used in biocidal products and are notified pursuant to relevant EU rules – have yet to be placed on one of list of substances I, IA and IB, biocidal products containing such active substances shall be placed on the markets of EU member states according to such procedures as laid down by respective national legislations. Biocidal products may be placed on the market of the Republic of Slovenia provided that they are notified and entered into
biocidal product register (only in Slovene). This transition period may last by May 2010, and may come to a close even before if of course a notified existing active substance in the framework of review programme included/not included into one of list of substances I, IA or IB, or later provided that evaluation and decision on inclusion/non-inclusion has not been completed within this space of time.
What do lists of substances I, IA in IB include?
Lists substances I, IA in IB are lists indicated in Annexes I, IA and IB Directive 98/8/EC, whereby:
Annex I list of active substances with requirements agreed at Community level for inclusion in biocidal products Annex IA list active substances with requirements agreed at Community level for inclusion in low-risk biocidal products Annex IB list of basic substances with requirements agreed at Community level
What are new developments when it comes to authorizations for placing biocidal products on the market following a 10-year review period?
Biocidal products may be placed on the market of the republic of Slovenia until the end of the review period provided that they are listed in the register and have relevant confirmations demonstrating this.
If there is any unforeseen hazard, extraordinary authorization may be granted for placing a certain product on the market. When it comes to new biocidal active substances used mainly in biocidal products that may be used in scientific purposes and development, authorization for research and development may be granted.
This set of authorizations (authorization for biocidal product due to its unforeseen hazard and authorization for research and development) and provisional authorization for biocidal products with a new active substance are categorised under extraordinary authorizations.
Once the transition period has come to a close, then, in addition to all mentioned authorizations biocidal products will be placed on the market based on: regular authorizations such as authorization (authorization according to complete procedure), registration (authorization according to streamlined procedure) and authorization according to a special procedure based on the frame formulation, as well as authorisation based on mutual recognition among EU Member States.
Basic differences among various authorizations are as follows:
Authorization according to complete procedure – authorization – biocidal products containing substances placed on the list of substances I. Authorization according to streamlined procedure - registration – low-risk biocidal products if their active substances have been put onto the list substances IA. Authorization based on mutual recognition of authorizations within the EU – biocidal products that have been either authorized or registered in any EU Member State in line with Directive 98/8/EC. Authorization according to special procedure based on a frame formulation – a group of biocidal products intended for the same type of use and containing the same active substances with the same specification; their composition, nevertheless, should not deviate from that of those biocidal products that have already been granted authorization for their placement on the market according to either authorization or registration procedures. This, however, relates solely to such a scope where any deviations imply the same of minor risk and have no impact on the efficacy of such biocidal products. The determination of the frame formulation is required on submitting the application for authorization or registration of the first biocidal product from this group. Provisional authorization for a biocidal product with a new active substance - biocidal products containing new active substances provided that procedure for inclusion into one of the list of substances is yet to be finalized; nevertheless, the competent authority of one of the Member States has confirmed the completeness of the application, and none of the Member States has opposed such findings on the completeness of the application after having looked into the dossier summary. Authorization for biocidal products due to unforeseen hazards – some biocidal products (there could be solely a matter of extending their use) provided that there is no appropriate biocidal product available or no other appropriate measures may be taken so as to prevent the development of any unforeseen harmful organism that could cause significant damage on human health, the environment and property. Authorization for research – biocidal products with a new active substance used for scientific research and development, as well as for research and development intended for use, or for research and development where no release into the environment is foreseen, as well as for research and development foreseeing possible release of biocidal products into the environment.
How does evaluation of biocidal active substances take place?
The first phase of review programme is governed by Regulation (EC) No. 1896/2000 describing procedures for application (identification or notification) of existing active substances, first of all by making an inventory of active substances having been on the EU market on the date of the entry into force of Directive 98/8/EC, i.e. May 14th 2000. Commission Regulation (EC) No. 1687/2002 extends timeframe for putting forward notifications of existing active substances.
The second phase of systematic evaluation programme is governed by Regulation (EC) No. 2032/2003 laying down procedures in evaluation programme, and its respective Annexes also include:
list of existing active substances, list of existing active substances and product types included in the review programme, list of existing active substances that have been identified, but in respect of which no notification has been accepted or no Member State has indicated an interest, requirements for complete dossier and dossier summary, lists including notified existing substances within the product types divided into 4 groups in terms of the evaluation priority, and for which the competent authorities of EU reporting Member States should within a set space of time receive complete dossiers (Table 1), list of competent authorities.
Regulation (EC) No. 1048/2005 amending Regulation (EC) 2032/2003 lays down conditions and procedure for use of significant importance, requirements for extending the time period for placing certain substances in the market, and its Annexes contain consolidated lists from Annexes of Regulation (EC) No. 2032/2003.
Table 1: Timescale of evaluation of biocidal active substances
Group of active substances Timeframe for submitting dossier to reporting member state Product types in line with Annex V Directive 98/8/EC
List A March 28th 2004 8, 14
List B November 1st 2005 – April 30th 2006 16, 18, 19, 21
List C February 1st 2007 – July 31st 2007 1, 2, 3, 4, 5, 6, 13
List D May 1st 2008 – October 31st 2008 7, 9, 10, 11, 12, 15, 17, 20, 22, 23
Biocidal products that will not receive dossiers for evaluation within timeframe laid down in Table 1 shall have their own time period set within which biocidal products containing such substances will be able to be placed on the market.
More detailed information regarding the evaluation of notified existing substances is available at: http://ec.europa.eu/environment/biocides.
Which are existing and which are new active substances?
All active substances that have been placed on the market in any EU Member State as an ingredient of a biocidal product prior to May 14th 2000 and have been notified or identified in accordance with Regulation 1896/2000/EC, are existing active substances. New active substances, on the other hand, are biocidal active substances, that were placed on the market as an ingredient of biocidal products after May 14th 2000 in any EU Member States until such time that they are placed on one of the lists of substances I, IA and IB as indicated in Annexes I, IA and IB of Directive 98/8/EC.
What is the difference between notified and identified active substances?
A distinction has to be drawn between 2 groups of existing active substances, i.e. identified and notified active substances.
Identified existing active substances are active substances without any support in the dossier or the withdrawal of such support, and shall therefore not be placed on one of the lists of active substances. Biocidal products containing identified existing active substances have been placed on the market since September 1st 2006. Notified existing active substances may be ingredients of biocidal products until such time that their inclusion procedure onto the lists has been completed at EU level and all requirements for inclusion into the lists of substances I, IA or IB have been met, not least because this is a prerequisite for biocidal products authorization.
Which biocidal active substances have been evaluated and placed on the lists of substances I, IA or IB?
Data on biocidal active substances (including assessment reports) that have already been included in the list of substances I and IA, Annexes to Directive 98/8/EC are available at:
ec.europa.eu/environment/biocides/annexi_and_ia.htm
LEGISLATION
NOTIFICATIONS
A large number of irregularities have been identified in biocidal products advertising. We would like to call upon you to dvertise biocidal products in compliance with Article 41 of the Biocidal Products Act (Official Gazette RS, No. 61/06) that, inter alia, stipulates that every advertisement should include the following text: Biocidal products should be used in a safe manner. Before its use always read the label and information on the product. Similarly, advertisements should not be misleading as to the use of biocidal products, their efficacy and hazards and risks that such products may cause, nor should such advertisements lead consumers to inconsiderate use of biocidal products.
More information on biocidal products is available at:
http://ecb.jrc.it/biocides
http://ec.europa.eu/environment/biocides
Contact Points: Marta Pavlič Čuk, Petra Čebašek
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