EUROPEAN COMMISSION Brussels, 7.6.2021 COM(2021) 287 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the implementation of Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance) {SWD(2021) 128 final}



Table of Contents 1.Introduction 2.Status of the implementation of the Biocidal Products Regulation 2.1.Active substance approval 2.2.Product authorisation 2.3.Treated articles 2.4.Poisoning incidents 2.5.Enforcement 2.6.Use of nanomaterials in biocidal products 3.Conclusions



1.Introduction Regulation (EU) No 528/2012 (hereinafter referred to as the BPR) entered into application on 1 September 2013 and lays down the rules for the making available on the market and use of biocidal products. It repealed Directive 98/8/EC concerning the placing of biocidal products on the market (hereinafter referred to as the BPD).

Biocidal products are designed to control organisms that are harmful to human or animal health or to materials (such as wood). Biocidal products play an important role in the daily life of EU citizens: e.g. insecticides and disinfectants are essential to help control vector-borne diseases, food-borne diseases or hospital-acquired infections. The crucial role of biocidal products for the protection of public health has been particularly highlighted during the COVID-19 pandemic, where disinfecting products are critically important in controlling the spread of the disease. The BPR establishes a two-step approach in order to achieve its objectives of improving the functioning of the biocidal products market in the EU, while ensuring a high level of protection for human and animal health and the environment. Active substances, which are the ingredients in biocidal products responsible for the action against the target organism(s), must be approved at the Union level or be included into Annex I to the BPR, which lists the so-called "low-risk active substances". In order to obtain an approval for an active substance, applicants must submit comprehensive dossiers, which are first assessed by an evaluating Member State. The assessment of the evaluating Member State is peer-reviewed by the other Member States representatives within the Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA). The BPC prepares an opinion of the Agency, which is the basis for the Commission’s decision on the approval. Approvals are time-limited, but can be renewed following the evaluation of a renewal application. Active substances are approved for specific product-types as set out in Annex V to the BPR, which defines 22 product-types. Subsequently, biocidal products containing such active substances require an authorisation - at national or Union level - before they can be made available on the market and used. By way of exception, biocidal products containing active substances that are included in the work programme for the examination of existing biocidal active substances (the “Review Programme”) can be made available on the market and used according to national legislation of each Member State pending the final decision on the approval of the active substance(s) they contain. Possibilities for derogation from the BPR rules are also foreseen in the event of a danger to public or animal health or the environment: in such situations Member States may grant temporary permits to make available on the market non-authorised products. Member States may also authorise products containing non-approved active substances for the protection of cultural heritage following a derogation granted by the Commission. Lastly, biocidal products containing a new active substance under evaluation may be authorised when certain conditions are met. This report has been established as required by Article 65(4) of the BPR, according to which the Commission, based on the reports submitted by Member States on the implementation of the BPR in their respective territories, is to draw up a composite report to be submitted to the European Parliament and to the Council. All Member States submitted their reports, except for the Czech Republic. Article 65(3) requires Member States to include in particular information on (i) results of official controls, (ii) poisonings, (iii) adverse environmental effects and (iv) use of nanomaterials. However, no information was provided by Member States on adverse environmental effects, due to the difficulty for Member States to gather this type of data for the first reporting. The Commission will discuss with Member States how to ensure that they will start gathering these data for the next report (due in 2025). The report covers the period from the entry into application of the BPR (1 September 2013) until 31 December 2019. In addition to the information provided by Member States, this report is also based on data extracted from the IT platform used for the submission and assessment of applications and on information contained in the overview report of the fact-finding missions carried out in 2017 and 2018 by the Commission’s Directorate-General for Health and Food Safety. This report is accompanied by a Staff Working Document presenting detailed evidence for the findings outlined in the report. 2.Status of the implementation of the Biocidal Products Regulation 2.1.Active substance approval Existing active substances in the Review Programme The Review Programme started under the BPD and was initially foreseen to be completed in 10 years. However, its duration had to be extended twice since it had become apparent that the evaluations of the application dossiers would not be completed within the initial deadline, first under the BPD - to 14 May 2014 - and then under the BPR - to 31 December 2024. The execution of the Review Programme still remains affected by significant delays. By 31 December 2019, only 35% of the related work has been completed. Commission decisions approving or not approving active substances were taken for 252 active substance/product-type combinations (of which 179 were adopted under the BPR), while 474 active substance/product-type combinations are still under examination. A steady increase in the number of decisions was recorded between 2014 and 2016, however, a significant decrease occurred in 2017 and 2018, as illustrated in Figure 1. Figure 1: Number of active substance/product-type combinations covered by Commissions decisions on approval/non-approval This decrease was caused by the falling number of evaluations completed by Member States. While 130 assessment reports were submitted overall by Member States to ECHA between 2014 and 2018, only 1 report was submitted in 2018 and 7 in 2019. The main factors indicated by Member States as causing the delays are: insufficient resources available, delays by applicants in submitting additional data required by Member States during the evaluation, complex technical questions on specific dossiers, evolution of technical guidance, and the adoption of new scientific criteria for the determination of endocrine-disrupting properties. The Commission and ECHA took action to address the continuous delays in the Review Programme. Already in 2015 the Commission sent letters to Member States, highlighting the importance of completing the Review Programme. In 2017, the Commission initiated discussions with Member States and stakeholders in order to understand the main causes of the delays and to identify possible actions for improvement. A list of actions was agreed in March 2018. In light of the results of a survey among Member States and of the information collected at a workshop of 2019, ECHA proposed an Action Plan that was agreed by the Commission and Member States’ Competent Authorities in February 2020. New active substances Innovation with regard to new biocidal active substances has been rather limited. Only 10 new active substances were evaluated since the entry into application of the BPR, of which 9 were approved, covering 13 active substance/product-type combinations. Exclusion and substitution criteria The BPR introduced exclusion criteria to ensure that the most hazardous active substances are phased out, and substitution criteria for substances presenting a specific concern. In principle, substances meeting the exclusion criteria cannot be approved, unless certain derogation possibilities apply. So far, 3 active substances meeting the exclusion criteria, covering 3 active substance/product-type combinations, and 4 active substances meeting the substitution criteria, covering 9 active substance/product-type combinations were not approved. 21 active substances meeting the exclusion criteria, covering 24 active substance/product-type combinations, and 20 active substances meeting the substitution criteria covering 37 active substance/product-type combinations are approved. Of the approved active substances meeting the exclusion criteria, 9 are rodenticides, which are deemed essential to control a danger to human, animal health or the environment in the absence of sufficiently effective alternatives; for the other 12 active substances the transitional provisions in Article 90(2) of the BPR applied, according to which the decisions on approval had to be taken on the basis of the former BPD, which did not contain exclusion criteria. To date, it is not yet possible to assess whether the exclusion and substitution criteria are a driver for the substitution of hazardous substances with safer alternatives. Nevertheless, the exclusion criteria provide a disincentive to apply for renewal of approval, since no application for renewal was submitted for 6 active substances meeting the exclusion criteria and 2 active substances meeting the substitution criteria. 2.2.Product authorisation As a consequence of the delays in the Review Programme, the majority of the products on the market (several tens of thousands) still fall under national legislations, which are very diverse among Member States. In many Member States only a notification is necessary before making the products available on the market, while in others products need to be authorised. Around 9,000 products are authorised according to the BPR rules following the approval of the active substances contained therein. The majority of products authorised under the BPR were authorised through mutual recognition procedures (around 6,400), and around 2,600 by standalone national authorisation.

As for the review programme for existing active substances, Member States do not respect the deadlines foreseen in the BPR for the various procedures for product authorisation. Especially for mutual recognition, more than 60% of procedures are delayed (about one third of them for 1-2 years and about half for more than 2 years). The BPR contains specific provisions for the resolution of disagreements that may arise between Member States in the context of mutual recognition procedures and these have worked well so far. Most of the disagreements were settled in the context of the Coordination Group, with only 8% of them resulting in a referral to the Commission. Products containing active substances which are candidates for substitution may only be authorised following a comparative assessment. 1,394 such assessments were performed, of which the great majority (1,289) led to the authorisation being granted without restrictions. Conversely, a simplified procedure is foreseen for the authorisation of products containing active substances which are less harmful. 232 products were authorised so far by the simplified procedure and altogether 474 notifications of making available these products on the market were submitted in the Member States. 138 applications for Union authorisation were submitted so far, of which 106 concerned biocidal product families. The Commission granted 11 Union authorisations, of which one concerned a single product, while the other 10 were for biocidal products families, for a total of 66 products. 183 applications for Union authorisation of so-called same biocidal products have been submitted so far, of which 105 concerned biocidal products families, and 2 authorisations were granted so far. Delays occur also in the Union authorisation procedures, in particular during the assessment by the evaluating Member State, and up to now it was not possible to complete any procedure for Union authorisation within the deadlines: about two thirds are delayed up to one year, about 20% between 1-2 years and about 10 % more than 2 years. Derogations from the requirements for authorisation Between 2014 and 2019, 9 Member States made use of the possibility foreseen in Article 55(1) and granted 135 temporary permits for products that they considered necessary to combat a danger to public or animal health or the environment. As of March 2020, almost all Member States made extensive use of this provision to allow the making available on the market of additional disinfectants needed to address the huge demand to control the spread of COVID-19. Almost 600 notifications of national permits were received by the Commission between March and November 2020. Eight months after the outbreak of the pandemic it can be concluded that this emergency measure in the BPR has allowed to address the unprecedented situation during the COVID-19 pandemic. Only one Member State granted a provisional authorisation for a product containing a new active substance not yet approved. By end of 2019, 2 Member States had applied for a derogation pursuant to Article 55(3) of the BPR allowing them to authorise products consisting of in-situ generated nitrogen for the protection of cultural heritage. 5 others applied in 2020. The Commission granted in all cases the derogation. 2.3.Treated articles Article 58 of the BPR contains provisions on articles which have been treated with or incorporate a biocidal product. A wide range of everyday products are treated with biocidal products, mainly for the purpose of preservation, for instance wood, paints, textile products. Such articles can only be treated with active substances allowed for the relevant product-type (either approved or included in the Review Programme, or for which an application for approval was submitted before September 2013) and have to meet any conditions or restrictions included in the approval of the active substance. The BPR also lays down specific labelling provisions for treated articles. The controls carried out by Member States between 2014 and 2018 indicated that relatively few articles were treated with non-allowed active substances, while non-compliance was higher with respect to the labelling requirements. At least 30% of the articles checked had an incorrect or incomplete label and in two Member States the non-compliance rate was around 80%. In 2019 Member States executed a coordinated enforcement project of the BPR Subgroup of the Forum. The results showed high compliance with the requirement that only allowed active substances may be used to treat articles. The controls also revealed very high compliance as to the presence of the label when required. However, when considering the quality and completeness of the information to be provided on the label, compliance was lower. In three cases Member States requested the Commission to decide whether a specific product was a biocidal product or treated article. Three such Commission decisions were adopted. 2.4.Poisoning incidents All Member States have appointed poison centres, but record poisoning incidents differently. The total number of incidents recorded varied between 5,248 in 2013 and 14,135 in 2018. The data available indicates that most poisoning incidents involved disinfectants (between 47% and 59% of the incidents recorded yearly) and pest control products (between 39% and 50%). In terms of severity of the incidents, the highest number of fatal or near fatal incidents - involving humans or non-target animals - involved pest control products. The most relevant exposure route causing incidents is ingestion for children and animals (pets), while for adults inhalation is the most prevalent. Most Member States have taken measures to educate the general public and raise awareness on the safe use of biocides and on the risks and benefits associated with their use. Encouraging the limited use of biocides and providing information on their safe use (especially of disinfectants and rodenticides) by all Member States could contribute to the prevention of poisoning incidents. 2.5.Enforcement Each Member State is required to ensure that an appropriate system of official controls is in place in order to enforce compliance with the BPR. Administrative structures differ between Member States and often more than one authority plays a role in the enforcement of the BPR. Overall strategies for enforcement of the BPR have been implemented in 20 Member States. In most cases they comprise both proactive (risk-based) controls and reactive controls following complaints. The compliance rate of the controls carried out by Member States in the reporting period vary greatly between Member States. Some Member States reported high compliance rates with the BPR rules for making products available on the market, while in others compliance rates were low. In some Member States the high rate of non-compliance might be related to the fact that most controls performed followed complaints concerning suspected illegal products on the market.