Placing on the market and use of biocidal products (debate) 
President
The next item is the report by Mrs Klaß, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products - C7-0036/2009 -.
Christa Klaß
Mr President, Mr Tajani, ladies and gentlemen, we have been discussing the Commission proposal to revise the directive concerning the placing of biocidal products on the market, which was adopted in 1998, for more than a year. We now welcome this proposal in particular because we are turning a directive into a regulation. Europe must fulfil its responsibilities. This also means that the areas relating to the internal market must be governed by clear regulations.
Biocidal products are part of our civilisation, and our standard of living depends on them. They are essential in order to maintain the high standards of health and hygiene on which we insist. When used as disinfectants and pesticides, they protect us from dangerous diseases or from their carriers. Given our high population density, our society requires particular forms of hygiene to prevent germs and diseases from being transmitted. However, our international mobility enables diseases, viruses and bacteria to move rapidly around the world. It is important that infections are not allowed to spread in hospitals. The laundries must be able to control and eliminate all the germs that are introduced.
Biocides are also used to protect wood, textiles, leather, rubber, brickwork and are a component of metalworking fluids. Biocides kill moulds, germs and pests and provide us with protection against them. They must be effective and, as a result, they can be hazardous if used incorrectly. This is why we need strict regulations. The benefits and the risks must be carefully weighed up against one another. Above all, biocides must not be used excessively. We must ensure that they are handled and employed responsibly. Using a little is highly effective, but using too much can cause damage.
Therefore, we need a strategy for the sustainable use of biocides which provides information about alternatives. We must be aware of one thing. This is not primarily about protection against biocides, but about the protection provided by biocides. If someone's hair is infested with lice, they must be able to combat the problem. However, they should first of all use a nit comb. If that does not help, then they can turn to a biocidal head lice treatment.
As nanotechnology is a new development, we must subject it to particularly critical scrutiny, because nanoparticles can get under our skin and directly into our water supplies. We must support research and innovation and not put obstacles in their path. We need to carry out more studies on biocides in water, as we currently have very little data available.
The objective of this regulation is to harmonise the internal market and introduce a streamlined procedure for approving active substances and products. For the first time, biocides will be subject to registration. It is obviously the right thing to do to organise and administer this properly on a European level. This brings genuine advantages for the internal market and for consumers. Parliament is calling for EU-wide approval of all products from 2017 and we are strongly supporting this call today. If we start drawing up a new regulation now, we must do it correctly and put it into practice within the required deadline.
The biocide market includes numerous different types of products and special applications, which are often only available in smaller quantities. We need this variety of different products in order to be able to combat the variety of harmful organisms. If we reduce the number of active substances, resistance among parasites and insects will increase, with fatal consequences. Therefore, we must ensure that the cost of registration and authorisation is kept within reasonable limits, particularly with regard to the many small and medium-sized manufacturers. Strict exclusion criteria are needed and it is right that they should be introduced. Parliament is proposing very clear exclusion criteria and defining limited exceptions in order to be able to meet the requirements of human health and the environment.
We also believe that consumer information is important. Therefore, materials that have been treated with biocides must also be included in the scope of the regulation. In future, materials sold in Europe must only be treated with biocides that are approved here. The serious health problems caused by fungicides used in the Far East on shoes and furniture which occurred last year have shown that we need stricter regulation and, most importantly, stricter import controls. This will provide protection for consumers and prevent the distortion of competition. On this basis, we have worked together to produce a compromise. I would ask my fellow Members to give their support to this compromise.
Antonio Tajani
Mr President, I should like to thank the European Parliament and, in particular, the rapporteur, Mrs Klaß, the shadow rapporteurs and the members of the Committee on the Environment, Public Health and Food Safety, for their considerable work.
The 330 amendments adopted by the Committee on the Environment and the global compromise adopted last week bear witness to their commitment to, and interest in, this dossier. These amendments support the general thrust of the Commission proposal.
Allow me to dwell on what we consider to be the main outstanding issues.
First issue: extending the EU authorisation system and related procedures. In order to reach agreement on this dossier, it is paramount that we reach a compromise on the study of the EU authorisation system and related procedures, especially the role of the European Chemicals Agency (ECHA).
Although the Commission can, in principle, support extending the EU authorisation system to a larger group of biocidal products, it can only do so on two conditions.
Firstly, the ECHA and the Commission must have sufficient resources to be able to take on the additional workload. Without sufficient resources, delays will ensue which will compromise the advantages of the EU authorisation system.
Secondly, we need to design a mechanism suitable for gradually extending the scope of the system, for example, by staggering the introduction of types of products or by applying horizontal criteria, such as similar conditions of use.
As far as procedures relating to EU authorisation are concerned, the role of the ECHA will be essential in terms of the operation of the system. We need to ensure that ECHA resources are used for work which brings added value in terms of harmonisation or which cannot be carried out more efficiently by the Member States. I would also add that procedures need to be designed to cope with the extended scope of the EU authorisation system.
Second issue: derogations from exclusion criteria. On the thorny issue of derogations from exclusion criteria, I note that the compromise amendment allows a reasonable balance to be struck between, on the one hand, the objective of guaranteeing a high level of protection for the environment and human health and, on the other, the need to make provision for a certain degree of flexibility in cases in which there is no substitution solution.
Third issue: national derogations within the framework of mutual recognition. Although we recognise that national derogations within the framework of mutual recognition may be justified in certain circumstances, we feel that the Commission should examine such derogations on a case-by-case basis. If such derogations are authorised without making provision for supervision by the Commission, there is a risk of compromising the internal market in biocidal products, which the regulation is designed to promote.
Fourth issue: definition of low risk products. As far as the definition of low risk products is concerned, we need to make an effort to establish a pragmatic definition as the sine qua non of an effective policy on such products. Efforts would still appear to be needed before a clear definition of the criteria applicable to low risk products can be reached.
Fifth issue: treated articles. As regards treated articles, we support the amendments pitching controls at the level of active substances. As regards the labelling of such articles, we endorse the general approach of imposing different rules, depending on whether the articles have an internal or external effect, for example, depending on whether or not the product was intentionally discarded or came into contact with human beings or the environment.
Sixth issue: free riders. Although we support the compromise amendment on free riders, we have serious concerns about a number of other amendments linked to the concept of inclusion by company.
Seventh issue: nanomaterials. On the issue of nanomaterials, the Commission has abided by its policy of taking a decision on the basis of scientific factors and its wish to improve knowledge of these materials and approves the need to define nanomaterials and, if necessary, the principle of their separate evaluation.
Finally: animal tests. Although the Commission supports the objective of reducing animal tests, it considers that this should not be at the expense of a high level of protection for the environment and human health.
I shall now follow your debate on the proposal and proposed amendments closely and may include further clarification of these issues and other points in my final comments.
Amalia Sartori
Mr President, Commissioner, ladies and gentlemen, I would like to congratulate the rapporteur, Mrs Klaß, on her fruitful collaboration, which has enabled me to enrich her report with some important positions taken by the Committee on the Internal Market and Consumer Protection.
I also hope she supports certain amendments that I have tabled with a view to tomorrow's vote and which are aimed at avoiding the double assessment of risks connected to products that have already been authorised and therefore assessed, unless new information is received that would justify the need for new controls.
I am also pleased that, even though it will be introduced gradually, there will be an opportunity for central authorisation that extends to all product categories. In this regard, I would like to ask Commissioner Tajani - although you have already mentioned some of these things in your report - how, and to what extent, it will be necessary to provide the European Chemicals Agency (ECHA) with the tools to smoothly and effectively handle the large number of dossiers that will be presented.
Richard Seeber
Mr President, I would like to offer the rapporteur, Mrs Klaß, and also Mrs Sartori, my warmest congratulations on the way in which they have worked with each other and with the shadow rapporteurs so successfully to produce a package that is, as I see it, politically acceptable to all the groups. It is important for us to remember that biocides are not an end in themselves. In fact, they perform many jobs in our modern society and Mrs Klaß has given us some examples of these.
The reason for using biocides is to fulfil consumers' requirements for increased food safety and improved health. There are many areas where biocides are used and, at the same time, the manufacturers' market is highly fragmented. I would like to focus, in particular, on the situation for manufacturers and also on the fact that the old directive was not able to meet the requirements either for improved health for consumers or for a well-functioning internal market for producers. One of the main problems is that we do not have an EU authorisation system for biocides. It is also important to make it clear that we need this EU authorisation system for as many groups of biocides as possible, otherwise the legislation will simply be a dead letter. I would like to defend the compromise reached on Article 33, which has made it possible for all the political groups to agree that the new regulation needs to be phased in and, at the same time, gives the Member States the opportunity to make exceptions in the case of particularly hazardous substances.
I believe that the package of compromises has been very carefully thought out. I would like to ask all my fellow Members to vote in favour of it.
Dan Jørgensen
Mr President, when we hear the Commission speak and when we listen to the conservative Members from the Group of the European People's Party (Christian Democrats), we could almost believe that this was merely a matter of finding solutions that are as simple and as effective as possible from a purely bureaucratic point of view. Naturally, that, too, is a real concern. Of course, this is also a matter of enabling the industry to market products and trade across borders. However, that is not the most important aspect. What is most important for us Social Democrats - and this is something that we will not compromise on - is health and the environment.
Nearly every day, there are new research results indicating that the overall chemical load that we, as people, are exposed to, and that our environment is exposed to, is increasing. We are seeing young girls reach puberty at the age of ten or eleven. We are seeing cancer spreading. New forms of cancer are appearing. We are seeing couples who are unable to have children. Many of these things are due to the chemicals that we are surrounded by.
Chemicals also have many beneficial effects; we do recognise that. However, if we know that there are chemicals that have extremely harmful effects, and we also know that there are alternatives to many of these chemicals, it goes without saying that we must replace the dangerous ones with the safe alternatives. This goes for biocides, too. The most important thing for us, therefore - and we seem to have achieved it to some extent with this compromise - was to get the dangerous substances replaced by safe alternatives.
We also insisted that if we allow a centralised process for approval, which may be a sensible thing to do, as it may, among other things, reduce bureaucracy, the individual countries must have the opportunity to say 'no' if there are special circumstances in a particular country that make it necessary to prohibit or to impose restrictions on a chemical in that country. We also said that it is not only a matter of which substances are placed on the market, but also of how they are used. We therefore insisted on new legislation being drawn up in the near future, namely, a framework directive on how to use biocides.
Finally, we insisted on there being as few animal experiments as possible. Too many animal experiments are currently used and there are alternatives. This was another of our objectives that we believe we have succeeded in achieving.
Corinne Lepage
Mr President, thanks to everyone's work, especially that of the rapporteur, we have achieved at least one objective. We have, after very difficult discussions, reached agreement on a key point of the authorisation procedure.
Our position on this issue went in the right direction. Firstly, we needed to guarantee the viability of the system, to clearly prevent the European Chemicals Agency (ECHA) from suddenly being inundated with requests to which it was unable to respond and, secondly, we needed to promote a system which encourages low risk products. A balanced compromise has been achieved on this point. It gives us time, as it allows four years for putting the system into place, and it offers a bonus for the least hazardous products.
For the rest, although we support the amendments to give the system flexibility, such as frame formulations, we refuse to allow this to be introduced at any price. The toxicity of certain products, such as pesticides, is clear, and I fully endorse the statements made by our fellow Member, Mr Jørgensen, about the impact of a number of products on health and the environment.
That is why we reject any provision which might call the quality of product assessment into question or detract from the system by encouraging the substitution of the most worrying substances, and why a series of amendments just tabled is completely unbalanced and cannot be supported.
Let us not deceive ourselves. This is the outcome of a position that gives priority to short-term interests over protection for health and the environment. We must never forget that health and the environment are not only values which we defend; it is also in the economic interest of society as a whole to defend them.
Michèle Rivasi
Mr President, I consider that progress has been made in this text, including on two fundamental aspects: the need for labelling if nanoparticles are present in a product and, more importantly, the fact that each of these nanosubstances will also be subject to separate evaluation, which is not currently the case. Progress has also been made in terms of the possibility of excluding endocrine disrupters from substances used, with specific and properly applicable exclusion criteria.
But - there is a but - we disagree on the actual resources for the European Chemicals Agency (ECHA), because that agency's mission should be to evaluate and authorise biocidal products.
However, we have just extended the ECHA's mission; we agree with that, but extending it means giving the ECHA the resources to really do its job. We cannot ask the ECHA to do a lot more work, to reduce substance evaluation times, while, at the same time, reducing its resources. If we do so, we risk coming up against simplified assessments, which may well be fast, but which will be superficial and therefore inadequate.
That is why I call on you, Mrs Klaß, to reconsider your budgetary proposal concerning the ECHA missions in this dossier. As it stands, I must say that your proposal is not a serious one, and this will affect the standard of work of that European institution, which is essential to the safety of European citizens and consumers.
This is an important issue. You cannot demand more if the resources are not available, or else the ECHA will just be an administrative agency which responds to the industrial lobby.
Julie Girling
on behalf of the ECR Group. - Mr President, I should like to thank Mrs Klaß. In my 60 seconds, I can only mention two issues in this important and complex dossier. The first is the issue of PBTs - persistent bioaccumulative and toxic substances. Biocides are, by their nature, toxic: they kill something, usually something nasty which is a danger to human health and often to animal health. So if anyone is tempted to vote in favour of Amendment 61, which would make toxicity the lone criteria for substitution, then beware: you will be cutting across the whole rationale of protecting public health and the environment.
This brings me to my second point: the substance Difenacoum. Amendment 243 seeks to restrict the use of this rodenticide to professionals only. A quick look in my local store at the weekend confirmed this active substance to be in about half of the products available, and all with clear instructions for use. Rodenticides create resistance: they need to be used in rotation to remain effective. Taking one product away will upset this balance and could lead to a major public health disaster. Please, colleagues, do not be instrumental in letting this happen.
Sabine Wils
Mr President, biocides form part of many cleaning products, disinfectants, insect sprays and other everyday products which people come into contact with in the course of their daily lives. There are currently more than 50 000 biocide products in the European Union. I would like to make it perfectly clear to everyone that biocides are mainly used by private citizens. Biocides are often non-biodegradable, in some cases, carcinogenic, highly toxic substances, and can cause harm to people, animals and the environment when they are being used and disposed of. People and young children in particular are especially at risk when biocides are used in the home, for example, in the form of wood preservatives and insect sprays.
It is true that the manufacturers say that their products are not hazardous if they are used properly. However, given that 400 000 tonnes of biocides are sold to and used by private individuals in the EU every year, it is important that improper use and the occurrence of accidents are taken into consideration. As this has not yet been the case, I have tabled an amendment on this subject and I would ask you vote in favour of it. This is Amendment 352.
Should the purpose of this regulation be to increase the free circulation of biocidal products within the European Union as the Commission has proposed? Or is this House more concerned with protecting people and the environment? It is essential that we introduce a strict ban on particularly hazardous substances. We must make a decision which supports the cause of consumers, otherwise we will be putting people's health at risk.
Oreste Rossi
Mr President, ladies and gentlemen, the term 'biocidal product' is used to designate the active substances or mixtures 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. To give a clearer idea of what we are talking about here, nearly all of the fruits and vegetables that reach our tables have been treated.
Although these products are now indispensable since most animal and plant parasites are becoming increasingly resistant to their effects, they must be kept under control because they often have adverse effects on humans. For example, some of them require a specific amount of time to break down after contact with food products, and for that reason, clearly defined types must be used during specific periods of the year.
Failure to comply with these timescales has serious consequences for people who consume treated products: from sudden allergic reactions to reactions associated with long-term use, which can include serious diseases or their precursors. Genuine poisons such as rodenticides, which are sold freely for domestic use, are also considered biocides. Unfortunately, even though allowing the free trade of these products may pose risks, we cannot conceive of prohibiting their use at a time when we are seeing a considerable increase in parasite and rodent infestations in European cities.
Particular attention must also be paid to the free movement of goods within the European Union, to the use of different types of biocides, whether permitted or not in the various Member States, and especially to the entry of goods from third countries where they are not yet regulated. We must guarantee, at EU level, that these products are used with the utmost seriousness and in strict compliance with the time required for their toxicity to break down.
Catherine Soullie
(FR) Mr President, as our rapporteur, Mrs Klaß, reminded us, biocidal products play an essential role, be it in the domestic - and hence private - sphere or in relation to public places. Biocides safeguard our hygiene and health on a daily basis.
It is important that we achieve a coherent Community text. It needs to be coherent, first and foremost, with other European legislation. REACH legislation, for example, cannot and must not come into conflict with the regulation on biocides. It is important to avoid administrative and legislative red tape which strangles and suffocates our businesses.
On this point, I should like to express my support for the compromise achieved by our rapporteur, Mrs Klaß, on the thorny issue of exclusion criteria and candidates for substitution. Similarly, the frame formulation approach for all biocidal products is an essential element of the regulation. It will significantly increase the efficacy of the Community authorisation system.
Then, it is a Community text. The introduction of the concept of centralised authorisation in the Union, and the simplification of the procedure and the reduction in the authorisation times for certain tests relating to research and development activities, are two initial positive steps towards the harmonisation of the European market in biocidal products.
Finally, we must not lose sight of our ambitions for this text: protection, of course, but the construction of our Community market and European innovation must also be an integral part of our approach.
Jo Leinen
(DE) Mr President, Mr Tajani, ladies and gentlemen, along with industrial chemicals and agricultural chemicals, household chemicals represent the third large group of substances which are of significance for the environment and human health, and we are introducing rules covering these products in the biocide regulation. I believe that we have made significant progress since the old directive which dates back to 1998. Other speakers have already mentioned this. We are introducing a comprehensive regulation which applies not only to products manufactured in the EU, but also to imported products. This is very important. We are improving the labelling of these substances and, as Mr Jørgensen has said, we are calling for animal testing of these products to be replaced with alternative methods. We want to see animal tests reduced to a minimum or even abolished altogether in this area. In addition, we want particularly hazardous substances to be replaced with substances which are less dangerous.
All of these measures represent progress and we can explain to the citizens of Europe that they will benefit human health and the environment. I was surprised about the level of disagreement as to whether or not the European Chemicals Agency (ECHA) in Helsinki should be responsible for monitoring and authorising these products. We want the same standards to apply throughout Europe and we want it to be possible for these products to be sold on the European market. For this reason, it is right that the ECHA takes responsibility for this area. I would like to ask Mr Tajani whether the ECHA has sufficient funding and the right organisation to be able to take on this task.
My thanks go to Mrs Klaß and to the shadow rapporteurs for achieving a consensus on this subject.
Frédérique Ries
(FR) Mr President, from my point of view, Amendment 18 to Article 1 perfectly sums up what should be our philosophy: we need to ensure a high level of protection for human and animal health and the environment and, at the same time, improve the functioning of the internal market.
Clearly, no one in this House wishes to question the use of biocides, which are very useful in combating rodents, cockroaches, lice - I understand that this is the time for lice in schools - and pests in general. The challenge actually lies elsewhere; it lies in their increasing numbers, in my opinion, with manufacturers putting more and more products on the market but balking at the idea of safer solutions. As the rapporteur said, more can be less.
The other major challenge is to find risk-reduction policies, which are too often postponed by governments when they are ambitious, and yet they are essential, because users tend to forget that biocides may be familiar substances, but they are still dangerous to use. The European Parliament also needs to spread this message of precaution.
James Nicholson
Mr President, I, too, would like to thank the rapporteur for her hard work. The regulation of biocides and biocidal products requires a balanced approach which takes into consideration the interests of manufacturers, on the one hand, and the welfare and safety of consumers and our environment, on the other.
I wish to say a few words on one aspect of this report. I was very concerned with the initial proposal from the Commission, which may have led to a ban on rodenticides. These substances are the most widely used products in the fight against rodent infestations and are a vitally important tool in the agricultural and agrifood sector.
I have received many representations from farmers and public bodies in my constituency, and other interested parties, who are totally opposed to such a ban, arguing that it would have serious negative implications for their respective industries. While the agriculture lobby may not be 100% happy with this regulation as it stands, I was reassured to see that the Committee on the Environment, Public Health and Food Safety passed some amendments which will hopefully go some way towards guaranteeing the exemption of these rodenticides. In this regard, I would urge colleagues to uphold the committee's position and vote for the relevant amendments in tomorrow's debate.
Paul Nuttall
Mr President, I must say that it is quite enthusing to see that there are so many MEPs who treat this place with the contempt I do. Out of the 736, there are fewer than 30 of them here - which is under five percent - and it is half four on a Tuesday afternoon.
As usual, EU rules and regulations are running out of control. But that is nothing compared to the rats and mice that will run out of control when the EU takes away common rat poison from ordinary householders. This is what Amendment 243 of this report will do. This daft piece of legislation will ensure that only professionals will be allowed to put down rat poison, which is freely available in shops. So, if rats are in your front garden, spreading their diseases and chewing everything up, the ordinary UK householder will be forced to wait for the Council rat catcher or have to pay for Rentokil.
We are already told that you are never further than 20 yards away from a rat in a city centre in the UK. This piece of crazy legislation will only make things worse. To put this into perspective, this is a piece of bureaucracy for a rat poison that has been safely used by ordinary folk for the past 30 years - not only in the UK, but across Europe and in the USA.
I will finish by asking a question. Why are you doing this? Do you want more vermin? Do you want more disease? Or is it just about control and your obsession with trying to govern every single aspect of our lives?
Horst Schnellhardt
(DE) Mr President, Mr Tajani, ladies and gentlemen, today's debate has shown that this was a very complex report and that we have now reached a good compromise. My thanks go to the rapporteur and to the shadow rapporteurs.
The compromise compensates for the deficiencies of the existing directive. It standardises the authorisation processes, which I feel is extremely important, and it provides comprehensive protection for human health and the environment.
However, in other ways the provisions do not go far enough. The point has been clearly made in the debate today that these products are very important for our environment, for the growth of the agriculture industry and for the food sector. I would just like to mention the example of rodenticides. Products for combating rats and mice are essential in the agriculture and food industries. I have seen the evidence of the problems caused by mice and rats which farmers have to contend with in their fields. These pests cause considerable losses. Anyone here who says that all the products which would help in this situation should be banned should think carefully about how to protect our food supplies.
This report is an effective solution, because it takes action against hazardous substances. If replacements are available, then they must, of course, be used. This is absolutely clear.
I would like to ask the Commission to focus more heavily on the new form of nanotechnology in its research and to make greater use of it. It will give us the opportunity to find substances which are less hazardous and more effective.
Mario Pirillo
(IT) Mr President, Commissioner Tajani, ladies and gentlemen, the proposal for a regulation concerning biocides that we are analysing is designed to simplify the authorisation and renewal procedures for the placing on the market of biocidal products.
This simplification will lead to a reduction in costs and administrative responsibilities for companies, especially for small and medium-sized enterprises, without reducing the level of protection of the environment and of human and animal health. It was very difficult to maintain a balance between these two aspects, but I believe that some of the compromise amendments proposed by the rapporteur and shadow rapporteurs, who I would like to thank for their hard work, represent an important step forward.
Precisely in order to remain consistent with the request for simplification, I believe that the comparative assessment procedure currently required for all biocides should not be required for biocides that have been demonstrated as safe for use. I hope that the amendment tabled along those lines in plenary will be adopted by my fellow Members.
Chris Davies
Mr President, it is good to hear the UK Independence Party confirming that they do not care a jot about animal cruelty, that they are happy to have the world treated like a giant chemistry set. Thalidomide and DDT would be on everyone's breakfast table if they had their way.
A concern has been raised here that we have seen in British newspapers, about the effect of banning anti-coagulant rodenticides and the question of whether this will lead to rat infestations in cities and towns. We have worked with the Commission; we have raised the issues brought to our attention by professionals; and working with the Commission, changes have been made. They are now in Article 5, and I believe they have the support of the Commission. That should deal with the major problem which has been expressed.
But there is the issue that Mrs Girling has raised: Article 44 about Difenacoum. I would like the Commission to explain whether it supports Amendment 243 because it seems to me that it contradicts in some ways the changes being proposed to Article 5.
Struan Stevenson
Mr President, I am delighted that attempts to ban all anti-coagulants and rodenticides have failed. Had such a ban won majority support, it would have led - as we have heard already - to an explosion of rats and mice across Europe, with the consequent damage to stored crops, farms and domestic properties on a large scale.
It is estimated that seven per cent of all house fires and 50 per cent of all farm fires are caused by rodents gnawing electric cables. Sadly, the Environment Committee did adopt one specific ban of a widely used second generation, anti-coagulant rodenticide. As we have heard, that rodenticide is Difenacoum. I hope the House will vote against Amendment 243 so as to enable this effective rat poison to continue in use, particularly as it has already undergone rigorous scientific assessment and has been through a proper and detailed regulatory process.
Anna Rosbach
(DA) Mr President, various hitherto unknown allergies, people with fertility problems, an increase in the incidence of rare diseases, poisoned fish and shellfish and food from animals filled with medicine residues are just some of the issues that concern the people of Europe. More and more chemical substances fill our everyday lives to make life easier for us and to make consumer goods seem a lot more attractive. Do these chemicals do us good? No, they certainly do not. Nevertheless, with this report, we now need to find a legislative balance between driving competitive enterprise in a sensible way while, at the same time, focusing on the environment and people's safety.
This is a difficult balancing act. I do not see a greater focus on the protection of people and the environment. Therefore, I can only recommend that we vote in favour of those amendments that set the highest safety limits. However, it will be a positive development if we can increase our chance of ensuring that EU countries do not import goods from parts of the world that do not meet our safety requirements.
Pavel Poc
(CS) We have to realise that biocidal medicines, while their use may be unavoidable, are simply poisons that we come into contact with on a daily basis. As such, they simply represent a risk to human health and a burden on the environment. It is therefore logically necessary to adhere to the highest levels of protection for human health, for animals and for nature. Excessive flexibility represents a considerable risk, because the risk is not only in these materials, but also in the ways of using them, and misuse as regards the quantities in which they enter the food chain. I would consider it a major success to have a complete ban on extremely hazardous biocidal medicines, including mutagenic and carcinogenic substances and substances that are toxic from the perspective of reproduction. The new legislation is and should be ambitious and, in my opinion, the ECHA is quite capable of commencing with the unified European licensing of biocidal medicines by 2015 rather than waiting until 2017.
Holger Krahmer
(DE) Mr President, it is good that we are looking at biocides, because they are hazardous, toxic substances. However, I am wondering why we do not base every piece of chemical legislation that we implement on the same system as that of REACH. We have passed the most comprehensive piece of chemical legislation in the world. The principles have been laid down: collect the data, evaluate it, authorise the product. Why are we using a different system for subsequent chemical legislation and defining new exclusion criteria, which ultimately also results in chemicals that we need and that, in some cases, do not have alternatives, being withdrawn from the market?
I think that we will end up in a blind alley if we draw up our policy on chemicals purely from the perspective of toxic substances. Pest infestations can be much more dangerous, in particular, for small children because of the risks of disease transmission, than the few milligrams of biocides which we use to combat them. I would like to see the situation being put into proportion and, most importantly, I would like to see regulations that can be used not only by large companies which have the resources to enter into a discussion with the authorisation bodies, but also by smaller companies which supply useful products for niche markets.
Ashley Fox
Mr President, the aim of this regulation is to protect public health and the environment. The current regime for authorisation is too slow and bureaucratic. We must ensure that the authorisation of new products is more efficient, both in time and money.
Pest control is central to the protection of human health. I welcome the amendments that will improve the availability of some products that kill rodents but, as has already been discussed, a problem remains over the treatment of Difenacoum. This is an effective and widely used rodenticide. It should be classified as an authorised substance. It is essential to the effective control of rats and mice. Its removal from Annex I by the Commission is simply irrational, and I invite the Commission to explain why this occurred. The authorisation of products should always be based on the result of scientific assessment, not by politicians seeking to grab a headline.
Csaba Sándor Tabajdi
(HU) Congratulations to Mrs Klaß, who has prepared a balanced report on an extremely complex topic, although debate did arise in the Chamber because some Members take the question of biocide regulation seriously while others want to reduce it to a fight against rodents. I wish to point out that this is a very serious matter, and the report excels by addressing environmental protection, consumer protection and chemical industry concerns simultaneously. The new biocide regulations add greater safeguards and protect housewives and domestic workers, but not pests. Therefore, I believe that we have to support the Klaß report, and that the fears expressed on the other side of Parliament lack foundation. Yes, there is a need for increased protection and the Helsinki Agency will perform this function with distinction. 2017 suits Hungary and the new Member States.
Jarosław Kalinowski
(PL) On the one hand, the chemical composition of biocidal products makes them quite dangerous, especially for people who are more susceptible, such as children or pregnant women. On the other hand, however, they are essential and simply indispensable for protecting human health.
Therefore, it is necessary to establish - and this, indeed, is happening - standards which are common to all EU Member States, so that people can feel safe and the firms which produce these substances will have clearly established norms which will not cause a reduction in their competitiveness. The harmonisation of legislation should cover the entire cycle of the existence of these products in the market, from production to waste management, so that they do not pose a threat to the environment or to human health. This should, indeed, be a priority. This does not mean we should not be concerned about maintaining good conditions for modern industry.
John Bufton
Mr President, the adoption of the report by Ms Klaß would undoubtedly see an explosion in rat populations, jeopardising sanitation in homes and on farms.
Rats carry diseases such as e-coli and salmonella and can cause significant damage to property, in some cases, leading to electrical fires. Farms, especially, fall victim to rat infestations without effective pest extermination. Anti-coagulants are the most widely used method of rat poisoning and are by far the most effective, accounting for around 95% of rodent control.
In May, I directed a written question to the Commission requesting formal acknowledgement of the implications of a ban and sought a support framework for those affected, as well as indications as to possible alternative pest control.
The Commission stated they were open to discussion with the aim of ensuring that appropriate solutions were found. What kind of solution does the Commission propose? Has there been an impact assessment into the prohibition of anti-coagulants as rodenticides? Will there be a viable support framework, and have alternative rodenticides been identified?
Antonio Tajani
Mr President, allow me to start by underlining once again how much the Commission appreciates the commitment and interest of the Members of this House on this dossier.
Although this is a highly complex proposal, it contains several important and sensitive aspects from a political point of view. The remarks you have just made and the questions you have raised illustrate just how well the Members of this House have understood the various facets of this issue.
I must also reiterate the Commission's concerns in terms of the amendments to the scope of the EU authorisation system. Although the Commission can, in principle, support extending the EU authorisation system to a larger group of biocidal products, we consider that this should be accompanied by sufficient resources for the European Chemicals Agency (ECHA) and the Commission, and gradual implementation mechanisms. It is only if these two conditions are met that we shall be able to implement an efficient system, which is our common objective.
As regards the questions raised by Mrs Sartori and Mr Leinen as to how to guarantee that the ECHA will be able to take on this workload in future, ensuring that the resources made available to the ECHA are adequate is one of the Commission's main concerns in connection with proposals to extend the scope of the EU authorisation system.
We are working with the sector in order to establish more precisely the number of biocidal products currently available on the EU market. Estimates vary from 9 000 to 60 000 products. It is therefore very difficult to forecast the additional workload that including a larger number of products in the centralised system would involve for the ECHA. The general objective of the proposal for a regulation is to improve the functioning of the internal market in biocidal products, while at the same time guaranteeing a high level of protection for the environment and public health.
I am even going to reply to Mr Schnellhardt on nanomaterials. The Commission agrees that we need a definition of nanomaterials. It is waiting for the outcome of the public enquiry organised by one of our scientific committees and hopes to be able to propose a definition which meets the criteria in the near future.
As far as Amendment 243 is concerned, I shall reply to Mr Davies. The Commission cannot support this amendment, because it calls into question Annex I, which is based on an in-depth impact study and which has just entered into force.
I am therefore satisfied that we have done a good job. We must continue the constructive dialogue between Parliament, the Council and the Commission at second reading.
Christa Klaß
Madam President, I would like to thank all my fellow Members for the debate today. However, sometimes I think that we do not really know what we are talking about. I would like to say once again that we are talking here about products which we and our standard of living depend on, which help us to meet important hygiene standards, which combat disease and parasites and which provide protection for stored goods. All of these things are covered by the term biocide. They are essential to us and also to our future. The main priorities in all our discussions were the environment and standards of health. It is clear that we are working to achieve clear exclusion criteria, limited exceptions and objective information for consumers.
Mr Tajani, I am not completely satisfied by the answer you gave on the subject of the European Chemicals Agency (ECHA). ECHA has the resources, it has the hardware, it can manage the REACH system and it can certainly do a great deal with regard to biocides in future. What we need now is simply some clever ideas. We will have time for this during the phasing-in period. Let us make use of this time to come up with some intelligent ideas together. It is not possible simply to say that we have no money and we cannot do it. If we want to do the right thing for the internal market, then the future lies in an EU-wide authorisation process. I invite everyone to take part and I am also asking the Commission for its support.
President
The debate is closed.
The vote will take place tomorrow at 12:00.
Written statements (Rule 149)
Elżbieta Katarzyna Łukacijewska  
The biocidal products market in Europe is estimated to be worth around EUR 890 million annually, which is about 27% of the global market. Biocides are used in domestic situations and in industry on a daily basis. These materials are used as disinfectants, preservatives, insecticides and rodenticides. When using biocides, however, particular attention should be paid to the safety of consumers, for it is important that the use of biocides should not pose a threat to the health or life of humans or animals. Therefore, we should conduct a thorough review of all biocides imported into the European Union and of their market turnover, especially as regards newly introduced products. Caution is also important when buying biocidal products, and the system developed in the Union should accomplish full unification on the question of legislation. In addition, within the Union's structures, a programme is under way to review the active substances used in biocidal products. The Union should draw up, to cover all Member States, a unified list of nanomaterials which are being tested and which will then be able to be used in chemical production processes. This will mean that nanomaterials, which may have a major impact on technological development, will not be excluded from the market, and that the environment and the health of consumers will not be endangered.
