The placing of biocidal products on the market - New biocides revision proposal (debate) 
President
The next item is the joint debate on the following:
Mrs Sârbu's report, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a directive of the European Parliament and of the Council amending Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods - C6-0346/2008 -, and
the Commission statement on the new proposal for a revision of the Biocides Directive.
Daciana Octavia Sârbu
I would like to emphasise that I regard as a success the agreement which we have reached together with the Commission and the Council on extending the period for evaluating active substances until 2014 in order to create in good time a regulated market for biocidal products.
This has also been reflected in the result of the vote taken by the Committee on the Environment, Public Health and Food Safety. This is why I would like to thank my colleagues who supported this compromise between the three institutions.
Extending the transitional period is extremely important for guaranteeing that all biocidal products containing active substances will be placed on the market legally.
I felt that it was essential for the review of this directive to be carried out at first reading so as not to risk going beyond the 10-year period for the systematic examination of biocidal products and, by implication, avoid the risk of their withdrawal from the market as from 2010.
The extension of the period will ensure that Member States have sufficient time to evaluate these substances up until 2014 when the substantive revision of the Biocides Directive will most likely come into force.
Another item proposed in the draft report is to limit to a maximum of two years the possibility of further extending the deadlines for the remaining dossiers through comitology in order to avoid the possibility of endlessly delaying the whole process. This measure is essential for the situation if the revision of the directive is not completed by 2014.
We hope that the aspects linked to data protection and the practice of 'free riding', whereby companies use the information registered by other companies as part of a national scheme, will be addressed during the substantive revision of the Biocides Directive.
I would like to mention that the amendments adopted within the Committee on the Environment, Public Health and Food Safety form part of an agreement with the Commission and the Council as they feature in the final draft due to be voted on in plenary tomorrow. Once the vote has been completed in the plenary, we will have the Council's support to reach an agreement on first reading.
Stavros Dimas
Member of the Commission. - (EL) Mr President, I should like to thank the rapporteur, Mrs Sârbu, on her diligence and efforts to achieve agreement at first reading on the proposal to amend Directive 98/8 on the placing of biocidal products on the market.
I should like to say that the European Commission is prepared to accept the compromise package, especially the point relating to the need to extend the transitional period by four years instead of three and the point relating to the two-year limitation on any further extensions, in order to facilitate the review programme.
Christa Klaß
Mr President, Commissioner Dimas, ladies and gentlemen, we can be proud of the fact that we have achieved such high health and hygiene standards in the European Union. The use of biocides has made a significant contribution to these achievements. When used as disinfectants and pesticides, they protect us from dangerous diseases, or as the case may be, from their carriers. Biocides are indispensable. They have to be harmless to humans and to the environment, and that is why we now need a review of all biocidal agents.
Safety requires time, and the review is now taking longer than initially planned. We cannot run the risk of losing important products because their registration has not been completed. That is why I welcome the fact that Parliament, the Council and the Commission have, at the first reading, agreed to a quick extension of the deadlines for the Biocides Directive, until - I think, Commissioner, - 2014.
However, why has this proposal appeared so late? The danger that substances might fall by the wayside due to expired deadlines, was something we could see coming for a long time, and our discussions in Parliament now have to take place under greater time pressure.
Commissioner, we have been waiting for some time now for a proposal from the Commission on the revision of the Biocides Directive. Important areas now have to be urgently harmonised and regulated. Examples include the definition of the approval criteria, the length of the approval and, most importantly, data protection. Manufacturers need clear regulations and certainty. Regulations are also needed when it comes to the use and handling of the products. The testing of an active agent costs several thousand euros, and this investment can only be recovered if the results, at least for a certain period of time, are not accessible to other applicants. No-one wants us to lose our high hygiene standards. We must keep them in order to meet new challenges.
I hope, that the Commission will present a clear and well-founded report that meets all of these requirements and I hope that it does so as soon as possible.
Vittorio Prodi
on behalf of the ALDE Group. - (IT) Mr President, ladies and gentlemen, thank you, Mr Verheugen, for coming and giving us the opportunity to discuss this document together. With regard to the proposal to amend the directive concerning the placing of biocidal products on the market, Parliament has agreed on the need to grant certain extensions to the review period required to correctly assess the main active substances of certain biocidal products, in view of the specific nature of the necessary tests and market requirements. However, you should be aware that we are awaiting the more thorough revision of Directive 98/8/EC on biocidal products to express our views regarding the content. I would therefore like to suggest some ideas for the Commission to think about.
First and foremost, it would be beneficial to make the transition from a directive to a regulation, a legislative instrument that would enable the same provisions to enter into force simultaneously in all Member States, thus regulating the sector uniformly. One key point will be the sharing of data, in accordance with EU guidelines, and, as already implemented with REACH, testing on vertebrates should be avoided or significantly reduced for biocidal products also, thanks to the mandatory sharing of data obtained through such tests among those who register the same active substance, thereby avoiding any duplication of studies.
Data sharing would allow for greater efficiency in the file evaluation system and would cut the cost of drafting these files, which would be significant both for small- and medium-sized enterprises and the national authorities responsible for examining applications.
Emphasis must be placed on simplifying procedures and applying mutual recognition of authorisation for a given product and its use among the different Member States, in order to speed up both procedures and the placing of the biocidal product on the market in the aforesaid States. Following this, the scale of charges and common time periods for examining applications in the different countries should be harmonised, and the authorisation process should be simplified in the case of formulations with minimal differences or variations in colour, for example, thus avoiding extra specific tests requiring further evaluation by each Member State.
Lastly, we must avoid discrimination between European producers of goods treated with biocidal products and extra-Community goods containing such products. I leave it up to the Commission to come up with a solution that the new Parliament, we hope, will be able to support.
Urszula Krupa
on behalf of the IND/DEM Group. - (PL) Mr President, harmonising the legislation on biocidal products in the European Union seems all the more necessary given that regulations in specific countries are very varied. The lack of common legislative provisions poses a danger to people's health and lives, as well as being an environmental threat, especially under free market conditions.
However, the proposal contained in the initial version of the text, namely a ten-year implementation period for the legislation, seems to be unrealistic, in view of the extremely complicated and expensive registration procedures for the chemicals used in these products. These procedures, which were intended to ensure a high level of safety, could, ironically enough, contribute to reducing the level of control, which is all the more problematic if we consider the fact that, in some cases, national regulations controlled the biocidal products introduced onto the market.
However, removing these mechanisms and introducing less efficient and expensive assessment procedures may restrict the sales of biocidal products. A central, European register of active substances used in biocidal products will not ensure safety, either, especially in view of the fact that biological agents are extremely variable and are resistant to active agents. Having a limited choice of effective compounds will only serve to increase resistance levels. Moreover, the high costs and complicated procedures involved will push small companies out of the market, leading to the market becoming monopolised by large companies working in this sector.
The proposal to have an extended, 14-year transitional period, which could be extended by another two years, has become all the more invaluable due to the fact that it will not be possible to register active substances or transpose these regulations into national law before 2014.
Zuzana Roithová
- (CS) Mr President, I would like to put a question to the Commissioner as I have rather a different opinion. I find it regrettable that the EU cannot manage in ten years, in other words by 2010, to complete a review and registration of the 900 or so disinfectants, preservatives and pesticides that are sold on the European market. It surprises me that we need a further three years for this, and the rapporteur has added another year on top of that. This means delays in harmonisation and therefore in greater protection for the market in respect of these harmful materials. Apparently we had no choice but to announce a postponement because otherwise many products would have to disappear from the market. Permit me, however, to offer a reflection. It might be beneficial if some of the products imported from uncontrolled Asian markets would have to leave our market. That would accelerate the development of alternative safer materials. I would be interested to hear whether the Commission has tried to cooperate with test centres and institutions in the Member States and to make use of their resources in order to achieve the original shorter deadline. Can the Commission or the rapporteur give me an answer to that question?
Czesław Adam Siekierski
(PL) Mr President, due to the specific nature of this legislation, and potential danger of any incorrect interpretation of it, we should pay particular attention to the issue of biocidal agents.
I agree with the rapporteur, who spoke about the fact that it is vital to extend the transitional period, for assessing active substances used in biocidal products, until 2014, in order to use EU legislation to regulate the market. If we were not to take this step, would the national provisions - which expire in 2010 - result in the sale of a significant number of biocidal products becoming illegal, which would lead to a variety of paradoxical situations?
During the transitional period, national legislation should be used to monitor strictly this specific section of the market. It is worth adding here that we should be particularly careful when dealing with any legislation concerning biocidal agents, and remember that these products are intended to destroy and repel harmful organisms and that they contain active chemical agents. Any carelessness on our part may have irrevocable consequences.
Stavros Dimas
Member of the Commission. - (EL) Mr President, I should like to thank the speakers for their constructive observations and to say that the evaluation of active substances will in fact ultimately require more time than was initially and optimistically foreseen. In 2000, when the legislation was passed, the evaluation programmes did not start immediately; approximately four years were spent on various preparatory procedures and the evaluation procedures which the national competent authorities are indubitably using only started in 2004. Although very notable and important work has been carried out to date, it will not be possible for many of the active substances to have passed through evaluation by May.
Given that the directive stipulates that biocidal products which contain active substances not included in Annex 1 or 1Α to the directive must be withdrawn from the market by no later than 14 May 2010, it was judged necessary to extend the deadline for completion of the evaluation procedure; otherwise, if we withdraw some of these substances because they have not passed through the evaluation procedure, then both health and the environment in the European Union may be jeopardised and, indubitably, trade will also be obstructed.
On the matter referred to by Mrs Klass, I should like to say that this matter concerns the protection of data submitted for the evaluation of active substances. This applies more specifically to cases in which companies which were not involved in efforts to produce the said data, 'free riders', can nonetheless keep their products on the market until expiry of the transitional period.
The Commission is in the final stage of processing the proposal for a substantive revision of the Biocides Directive and this matter was clearly signalled during the consultations carried out when the said proposal was being formulated and drafted. Many of the comments made by Mr Prodi and others will doubtless be taken into account.
The Commission will address the aforementioned issue within the framework of the substantive review of the directive. A Commission statement on this will be sent to the European Parliament secretariat for insertion in the Minutes of today's sitting.
Similarly, numerous other matters highlighted by Parliament will also be addressed in the said proposal, such as the extension of the scope to goods and materials processed using biocides, improved approval procedures for biocidal products, the introduction of compulsory data exchange during product licensing and during approval of the active substance in accordance with the principles of the REACH regulation and alignment with best practice in other legislative acts, such as that passed recently on plant protection products.
To close, the Commission expresses its satisfaction with the outcome of the negotiations. The Commission is in a position to accept the compromise amendments in full and promises to take account, during the main review of the directive, of the concerns about data protection expressed both by the Council and by Parliament here today.
Commission Statement
The Commission notes the issues concerning data protection, data sharing and 'alleged free riders' that have been raised during the discussions on the proposal for the extension of certain time periods under the Biocides Directive. The Commission will consider appropriate solutions to the identified problems in the framework of the substantive revision of the Biocides Directive.
Daciana Octavia Sârbu
I would like to thank again my colleagues, the shadow rapporteurs, with whom we cooperated very well. We were very efficient in completing this report, although this is not as important as the actual revision of the directive will be.
As you have seen, all my colleagues have talked about this revision and less about the report which we are discussing today because it is a revision that we are waiting for.
We have heard here, admittedly, that this extension of the transitional period from three to four years is not desirable, but I believe that it is much more important for us to guarantee that all products will be placed on the market legally and that a proper evaluation of these products will be carried out.
Thank you once again and, as I was saying, we are waiting for the revision of the Biocides Directive as soon as possible.
President
The debate is closed.
The vote will take place on Tuesday, 24 March 2009.
