Klaus BEREND

What Klaus BEREND has said (8)

• “Yeah, thank you, Mister Chairman, and thank you to the honorable members for the questions. To start with Mister Clerzo's remarks and questions, let me first emphasize very strongly that we share your frustration about the delays in the execution of this review program for the existing active substances, which started in 2000 and was originally scheduled to end in 2010. We are now in 2025, and we have only completed fifty-two percent of the program. This has been an enormous frustration for the Commission, which has for at least ten years reminded the member states of the need to increase the resources available in their competent authorities to conduct the work. Our report in 2021 is testimony to that. The bottleneck is not so much ECHA and the resources that are available in ECHA; it is really in the member states because they have to deliver the first assessment reports. But a number two reason for the delay is indeed also the attitude of certain applicants who did not react timely to requests for additional data or who entered into long negotiations with the authorities on whether additional data are really needed or not. This is a reason why we are not proposing lightheartedly now any change to the end date for data protection that the Council and the Parliament had originally set. Bringing me to your other questions, it is true that the establishment of the criteria for endocrine disrupting properties has triggered the need for generation of a lot of data, often involving vertebrate animals, as asked about by Mister Jonas. The demand on the applicants to generate this data only came after the criteria were adopted, so this is really an objective factor. If we leave the end date for data protection in 2025, these data would only have a period of protection of maximum seven years or even less. We know that some member states have only now asked the applicants to generate this data, so they would have no data protection at all. That can also not be in the interest of the Commission or of the members of Parliament because it could lead to a decision by applicants to simply withdraw the dossier and not invest the money in generating these safety data. Then the substances would disappear, and some of them are indeed needed for society because they serve functions such as disinfection, mosquito control, wood preservatives, or other functions that are really useful to society. Is our intention to limit this to the data that are linked to endocrine disruption? That's indeed, for the moment, our initial thinking, but we are open to further observations and comments in this regard, in particular for a situation where an update of a technical guidance document that existed in 2010 said we should have these tests, but then it was updated in 2015 to say no, we need additional tests. Maybe they are in a similar situation, so we will look into that as well. Are we not incoherent in doing this before the full evaluation of the regulation? It could seem like that, but given that the problem is very urgent because once the data protection expires on 31st December 2025, it is indeed open game, as you said, Mister Clerzo, and companies who have not contributed at all to the costs for the review program of existing active substances could also start selling in the EU. That would be very detrimental for the diligent companies who have invested all the money in generating the data. Therefore, we believe that this correction or change should be proposed urgently while the full evaluation of the regulation will take a couple of years, and by then the damage would be done already. To the questions of Miss Bonde, it appeared to me that there's a bit of confusion. Biocidal products are not intended for farmers; these are plant protection products. Biocidal products are non-agricultural pesticides, so they have other functions and are very different from plant protection products. The users are not farmers. The secrecy you referred to is also not really the issue here. Data protection is different from confidentiality. A study that is publicly available can still be protected under the rules of exclusivity of data protection but does not have to be secret. These are very different rules altogether. Miss Paolusia, thank you for the position that indeed when the legislation needs to be amended in order to serve overall its purpose, then it should be done. That is exactly what we are reflecting on at the moment for this particular aspect.”
  EU policy on pesticides
• “Yes, I will manage in less than ten minutes. Um. Thank you. Let me first pick up on something that Mr. Clergeot said very clearly, and that is that the Commission has not decided anything and is not proposing pursuing any particular decision at this moment in time, and has not tabled any intention of any decision at this time. Um, the Biocidal products regulation foresees two very distinct processes. The risk assessment, the scientific assessment done by the experts and leading to an opinion of the Biocidal Products Committee in the European Chemicals Agency. And only when that opinion is available will the Commission start discussing with the member States the risk management decision to take. So, uh, in response to, I think in particular, Mr. Vondra, um, and, Mr. Walker, we have no intention, uh, to ban ethanol. That is absolutely not correct. The scientific process is ongoing, as I explained. And one of the questions for Mr. Nordquist was, why has the Biocidal Products Committee not yet finished its work and delivered its opinion? And the reasons are twofold. The first is that there is a need, indeed recognised among the members of the Committee, to further examine the different exposure routes and the data available for different exposure routes in relation to the hazards and potential classification. Uh, and to respond to another question from Mr. Nordquist. The dossier contained, uh, data that were all based on oral intake, um, of ethanol. But during the public consultation that Echa ran on request of the Commission to examine the availability of alternatives, uh, more information was brought in by those responding to the consultation, also referring to exposure via other routes and effects not seen, uh, via exposure by these other routes. ****Klaus BEREND (DG SANTE): So all of that will have to be examined further and described more extensively in the opinion. And the second reason why the delay occurred is that there is also a need to further reinforce the analysis of availability of alternatives. And that brings me to questions by Miss Wexler and also others. Yes. The committee will examine the question of are there alternatives to ethanol available in sufficient quantities and for all users, so that in case in case any potential restrictions are necessary, there would not be unwanted consequences as described by several honourable members, and that will be further this analysis will be further conducted. Also, real world conditions will be taken into account as requested by by Miss Wexler. In particular, the different routes of exposure and the way disinfectants are used compared and very different as everybody recognizes from drinking ethanol containing beverages. And yes, the Commission will of course consider all possible impacts before it takes a decision. Several members asked about that. It will look into socio economic consequences of its decisions as it as we usually do for all active substances. By by the way. Um, we will also make the distinction between hazard and risk. And as noted, I think, by Mr. Nordquist, um, the Biocidal products regulation explicitly foresees that even if a certain classification in the end is decided, um, it is possible to foresee derogations. And also in this particular case, ethanol, uh, where the application was submitted almost 20 years ago, it still falls under the decision making criteria of the Biocidal Products Directive, which are exclusively risk based. ****Klaus BEREND (DG SANTE): They are not hazard based. So yes, that distinction will also be made and risks will be considered in addition to only a hazard and also to respond to. Miss singer. The Commission has not a reflex to go for bans. We always look at the available scientific information and possible risk mitigation measures before taking decisions on active substances, and the member states do the same before they take decisions on biocidal products. So there is no automatic ban, ever, without consideration of other ways of addressing risks if they are identified. Um, the question from, uh. Mr.. No. Who was it? Uh, somebody asked about coherence with other legislation. Um, and here I would like to mention that indeed, the Commission will start a full evaluation of the Biocidal products regulation now, and it will be concluded in the course of 2027. And we will examine all its provisions, including the provisions that at the moment are linked to hazard classification. So all of this will be examined. And the evaluation will also examine coherence with other legislation, including with the Reach regulation. So yes, we will look into that as part of this evaluation. Um, and uh, then maybe, uh, should Mr. Vondra called very strongly for kill this process and others said we should end the process, uh, whereas others said we should, uh, close. I think, Mr. Schmidt, in the end, we should close the process with a clear outcome. ****Klaus BEREND (DG SANTE): And that is exactly the. If we have an intention, that is the intention. Uh, no longer let this process that has already been hanging for almost 20 years continue. We need an outcome. We need a clear outcome, and we will indeed work in that direction. Um, considering the scientific evidence as it comes out from the risk assessment and the hazard assessment conducted by Echa, and then taking into account all other factors such as socio economic considerations and the importance of ethanol as a disinfectant in the health sector. So I can really give that commitment, that very firm commitment from the Commission, that all these factors that have been mentioned today by many of the speakers will be taken into account. And I would very much also confirm what Mr. Tsiodras and Mr. Nordquist and Mr. Casu have said, that, uh, the scientific, scientific facts will be considered objectively in the assessment that is currently conducted by the European Chemicals Agency. And the last question from Mrs. Schneider. Uh, is there a risk of moving industry to third countries? Um, first of all, uh, all said, we have no intention yet as regards any particular regulatory decision in relation to ethanol. And secondly, if one was taken, it would apply to all biocidal products containing ethanol independent of whether they are produced in the EU or in third countries. The same rules apply for all products and I hope that with this I have covered most of the questions. Um, thank you, Mr. Chairman.”
  EU measures on lifestyle-related behaviours (smoking, drinking, eating, etc.)
• “Thank you, Madam Chair. Um, I will respond to some of the questions that were addressed concerning the authorization and use of pesticides. Uh, to Mr. Dorfman's remark, um, I would like to emphasize that pesticides used in organic agriculture are a subgroup of those that are allowed for conventional farmers, and the way they are checked and risk assessed for their impacts on pollinators is exactly the same as for those used in conventional agriculture. So there are no shortcuts there. Um, to Mr. Royston, yes, we agree that precision agriculture has a has a big potential for using for reducing the use of pesticides and applying them in a more targeted way, which is why we are working with the member states and with the European Food Safety Authority to make it possible to integrate modern application techniques and exposure reductions they bring into the risk assessment process for pesticides. You also asked about what are we doing to bring more alternatives to the market, in particular biocontrol. And this was also asked for by Mr. Stoyanov. Um, and indeed in the vision for Agriculture and Food, we have announced, the Commission has announced that it will come forward with a proposal by the end of this year to accelerate market access for biopesticides. And this will be part of the simplification omnibus that my director general is preparing. Um, Mr. Weitz and Mr. Hausling, um, rightly said that it's not the volume alone, um, of pesticides that matters, but also their properties.”
  EU policy on pesticides · Reduction targets for pesticides · Digital and precision farming
• “Thank you, Mister Chairman, for the floor and also for having introduced these concerns from some industry actors about the end date for data protection for all existing active substances that are still in the review program under the Biocidal Products Regulation. That date is the 31st of December 2025. As you mentioned, there are reasons why the Parliament and the Council set this limitation in the Biocidal Products Regulation. So it's not really a derogation but an explicit limitation that the co-legislators adopted in 2012, together with a new requirement that every active substance supplier must be included in a list established by the European Chemicals Agency (ECHA) under the condition that it is either a participant in the review program or an alternative supplier that has obtained a letter of access to the relevant protected data from the review program participants. Alternatively, a supplier would have to submit its own data package on the active substance. The purpose of this approach was to ensure that all active substance suppliers contribute to the costs for proving the safety of active substances that they place on the market, in line with the principle we all know from the REACH Regulation: the no data, no market principle. The inclusion in the list of suppliers has been mandatory since 1st September 2015, and only biocidal products containing active substances coming from companies on the list can be placed on the EU market. Data submitted in an application for approval are usually protected from the day of submission until ten years after the date of approval of the active substance to ensure fair compensation for the costs of generating the data. In a way, it gives market exclusivity for the companies on this list established by ECHA. Afterwards, when data protection is over, other companies have free access to the data, so there is more competition and lower prices for buyers of active substances and ultimately also for users of biocidal products. This follows common principles established under other regulatory frameworks to grant a limited period of data exclusivity to give incentives for innovation or support of a substance under a registration procedure, while allowing generic manufacturers to come to the market without the need for a letter of access or their own data after that period to bring down overall costs. To avoid overly long data protection periods, the Council and the Parliament decided to limit the data protection period to 31st December 2025, basically ten years from the date as of which all companies had to be listed in this list of suppliers established by ECHA. This limitation must have been a firm view of the co-legislators at the time because they did not give empowerment to the Commission to extend the duration of the data protection period, which is different from many other elements in the regulation, including the length of the review program, for which the Commission was empowered to extend its duration. Because of significant delays in the review program, the Commission was obliged to extend the duration of the program twice, and it's now set to end in 2030. The Commission reported in June 2021 to the Council and Parliament on the substantive delays and the reasons for these delays, which are primarily the lack of resources allocated in member states' competent authorities for completing their tasks under the Biocidal Products Regulation, but also delays by applicants in submitting additional data when requested by evaluating member states, in light of the often poor quality of the dossiers submitted initially. It must be recognized, though, that one particular element led to significant additional delays beyond the control of applicants: the adoption of new scientific criteria for determining endocrine disrupting properties in 2018, which triggered the need for significant further data generation and their assessment. Also, adoption of new technical guidance or updates of older technical guidance documents may have triggered the need for additional data that could not be contained in the original application dossiers. The Commission has heard the concerns expressed by many industry actors, to which you have referred, Mister Chairman, that data generated since 2018 will not benefit from an adequate period of protection if all data protection ends on 31st December 2025, as now set in Article 95 of the Biocidal Products Regulation. This was particularly mentioned repeatedly during the implementation dialogue on the regulation that Commissioner Wojciechowski organized on 15th July this year. The Commissioner indicated that the Commission will reflect on a solution that could be proposed to Council and Parliament as part of the cross-cutting simplification package announced in the vision for agriculture and food, and it was announced for the end of 2025. The Commission has just published a call for evidence on the package last week, and all stakeholders can submit comments until mid-October. In particular, when reflecting on the matter we are discussing today, it seems justified to extend the protection period for data generated to assess endocrine disrupting properties due to the regulatory actions taken in 2018 to set new criteria that necessitated the generation of new data. However, there is a need to strive again for a fair balance between the interests of the review program participants and the interests of other relevant stakeholders, both in terms of the data concerned by an extension of the protection period and the duration of the extension. In fact, the Commission is also often contacted by companies who report difficulties in obtaining letters of access to protected data or in getting agreement from established participants to join them in the support of the substance. They would benefit from an end of data protection and free access to data. These companies are not only companies established in third countries, as often suggested by industry, but also can be European companies, in particular European SMEs. We will have these elements in mind and will consider all information submitted in response to the call for evidence when preparing the simplification package by the end of the year. Let me also remind you that we plan a full evaluation of the Biocidal Products Regulation starting this year, as announced already in the report submitted to Council and the European Parliament in 2021. Thank you very much for your attention.”
  Pharma IPRs
• “Thank you madam. Thank you, Madam Chair, for the floor and for the opportunity to complement the information provided by my colleague from the environment with further elements on the actions that are under the responsibility of DG santé. We are working with the Member States to improve the implementation of the directive on the sustainable use of pesticides, in particular towards a better implementation of Creation of integrated pest management, for example, with the organization earlier this year of a research and innovation webinar on pesticides and IPM that was attended by more than 280 participants. We are also having regular meetings with the Member States competent authorities for the implementation of the directive. The Commission's Joint Research Centre is working on options for improving the harmonised risk indicators established under the directive. In the meantime, the existing indicators show that there is indeed already an overall decrease in risk and use of chemical pesticides, which is also reflected in the decreasing sales of pesticides in the EU. The latest data from Eurostat show that in 2023, the sales figures were at the lowest level since 2011. We are also making progress to reinforce the pesticides risk assessment for bees in the context of the regulation on the placing on the market of plant protection products, in particular to endorse the new FCB guidance document. This requires amendments of the regulations, setting out the data requirements for application dossiers and the Uniform Principles for Evaluation and Applications of the Evaluation of Applications for authorisation.”
  EU policy on pesticides
• “We fully agree with that. Um, and that is why we have indeed, uh, either banned or restricted pesticides in recent years, um, because of their unacceptable impacts on pollinators. Um, and indeed the timing of their use. Everything that Mr. White's mentioned is perfectly right. There are risk mitigation measures, mandatory risk mitigation measures that certain pesticides can only be used at times when there are no pollinators flying, or only when crops are not flowering, when there are no flowering weeds, etc.. So all of this is being set in the authorisation conditions for pesticides. Illegal use of pesticides, as referred to by Mr. Stoyanov, is indeed a problem. Uh, Enforcement and monitoring are, of course, primarily the tasks of the Member states, but we monitor their systems for doing so. And together with Europol and Olaf, there is every year an action taken to detect and combat illegal and illicit pesticide use. And the last point from Mr. Hausling about the numbers, the reduction figures that I mentioned, these are from the latest figures published by Eurostat in July this year. And it's not just the tonnages, but also the risk indicators, which show a reduction of 58% in the risk and use of pesticides in 2023 compared to 2015 to 2017, and 27% reduction for the more hazardous pesticides. Thank you.”
  EU policy on pesticides
• “Thank you very much, Mr. Chairman. Um, as as you and others very well know, an application for the approval of ethanol as an active substance used in Biocidal products is currently under evaluation in the context of the European Union's Review programme of existing active substances established by the Regulation on Biocidal products. It is used, among others, for hand disinfection and in disinfectants. For surfaces, the decision on whether to approve ethanol as an active substance for biocidal use will be made by the Commission, based on the opinion of the Biocidal Products Committee of the European Chemicals Agency. As for all active substances, a part of the BPC opinion will assess the intrinsic toxicological properties of ethanol and the classification that should be assigned to it in the light of the criteria established by the regulation on the classification, labeling and Packaging of chemicals, and this will also include an assessment of whether ethanol has carcinogenic, mutagenic, or reprotoxic reprotoxic properties. The meeting of the Biocidal Products Committee that took place on 26th November discussed a first draft of its opinion on ethanol, but it did not adopt the opinion, yet the committee needs additional time to discuss further the possible CMR properties of ethanol, considering more in detail the available evidence in relation to different exposure routes and its potential alternatives for use in disinfectants. The committee is expected to continue its discussions at its next meetings in February 26th and adopt its opinion. Uh, probably, but also at the earliest, in May 2026. Mr. chairman, I can assure you that we have taken good note of all the concerns that were raised by stakeholder organisations, by member States, and also by several honourable members of Parliament. ****Klaus BEREND (DG SANTE): In recent letters on the possible implications of a determination under the Biocidal Products Regulation that ethanol would have a CMR properties. Um, I would like to note that even if the BPC finds that ethanol has CMR properties, the Commission can still approve its use in disinfectants under the Biocidal Products Regulation. If it is concluded that the representative product poses no unacceptable risks to human health, animal health or the environment. In fact, once the Biocidal Products Committee will adopt and submit its opinion, the Commission as risk manager will discuss the outcome with the Member States in the Standing Committee on Biocidal products to prepare a decision on the approval of ethanol. And these discussions will fully take into account the specific elements raised by stakeholders, Member States and members of the Parliament, including also the consideration of the different routes of exposure. Let me also emphasize that any future decision that will be adopted under the Biocidal Products Regulation will only concern the uses of ethanol in Biocidal products, and it will not concern other uses, for example as solvents in the chemicals industry or uses in food. Finally, I would like to clarify that the outcome of the assessment under the Biocidal Products Regulation will not determine the harmonised specification of ethanol under the Regulation on Classification, Labelling and Packaging, which is a separate and independent process. And my colleague Veronica manfredi from DG environment will give you more information on that process.”
  Chemicals regulation · Classification, labelling and packaging of chemicals
• “The draft regulations to make these changes were published for feedback, and a period for feedback ends today. The Commission can adopt these regulations if the Member States support them in a vote in the Regulatory Committee, and if afterwards, the Council and the Parliament do not object during the scrutiny period and after the adoption of these regulations, the updated guidance document itself can be endorsed by the Member States, and we expect this to happen in early 2026. And if completed, it would be the first significant pro. It would the first significant progress for better protection of bees since 2002, and it would end a very difficult process that started in 2013. Already. For the further actions, we have developed a work plan with regard to missing test protocols for pollinators and together with the member states, three draft test protocols have already been submitted to the OECD for international recognition. Furthermore, we continue to monitor the emergency authorizations granted by the Member States. We have mandated Efsa to develop specific protocols to evaluate the justifications for the need of emergency authorizations, and the public consultation on the first version of these protocols is ongoing via the Efsa website. Once available, it will help the Member States to assess requests for emergency authorizations and ensure more harmonisation. And finally, since March 2023, we have set out criteria and procedures for identifying unacceptable coformulations in plant protection products, which completed action 6.6 of the Pollinators initiative. Thank you for attention.”
  EU policy on pesticides