Biocidal product regulation the changes to come The Biocidal Product Regulation, which came into force on 1 September 2013 is still changing. ECHA announced the evolutions of this changing regulation during its Biocides Stakeholders Day held on 24 September 2014 in Helsinki. All actors (active substance manufacturers and suppliers, biocidal product formulators and providers, importers) are concerned by the recent evolutions particularly impacting the Review Programme, treated articles and IT tools in particular. Margaux Tanguy and Aurélie Lemétais 4 November 2014 Since its entry into force in September 2013 (Regulation No 528/2012), the following amendments have been implemented: - The Review Programme for existing active substances has been postponed until 2024 (Regulation No 736/2013 entered into force on 20/08/2013) - The information required for biocidal product authorisation applications and the notion of technical equivalence have been specified (Regulation No 837/2013 entered into force on 23/09/2013) - The transitional period has been affected (Regulation No 334/2014 entered into force on 25/04/2014) Since 10 October 2014, a new amendment repeals the Review Programme for existing active substances: Commission delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council. New Review Programme Why? The implementation of a new Review Programme for existing active substances was necessary for two reasons: the first was due to the postponing of the Review Programme until 31 December 2024 (Regulation No 736/2013) and the second because of the procedures revision to be in line with the BPR (Regulation No 837/2013 and No 334/2014). 04.11.2014 EcoMundo Page 1
How? Regulation No 1062/2014 establishes a new Review Programme by introducing procedures of inclusion for additional existing active substances; as otherwise, these substances would be on the market illegally. The topics of the new Review Regulation are organized as follows: Articles 3 9: Process and procedures Review Programme Article 10: Joining or replacing participant Articles 11 12: Participants withdrawal This could already be done under the Directive, but now, there is a clear process to first, withdraw a participant and then, replace him. Article 13: Redefinition of active substances (not in the Directive) For example, this was the case of the Margosa extract, which had a definition in the notification dossier and which has been redefined during the evaluation. Article 14 1 : Taking over the role of participant Article 15 2 : Substance/product-type combinations eligible for inclusion in the review programme Article 16 3 : Declaration of interest to notify Article 17 4 : Notification Article 18-20: Follow-up notification process Article 21: Transitional measures including phase-out periods Article 22: Essential use (already in the Directive) Annex I: Information requirements for notifications Annex II: Substance/product-type combinations included in the Review Programme on 4 August 2014 - Part 1: Active substance/product-type combinations supported on 4 August 2014, which means the substances that are still under evaluation in the review Programme - Part 2: Active substance/product-type combinations not supported on 4 August 2014 Annex III: Time limits by product-types, for submitting the assessment report of the competent authorities (RAC) and for starting the preparation of the Agency s opinion (The Biocidal Product Committee s opinion) Note: Active substances generated in-situ are not included in the new Review Programme. When must you notify? ECHA gives the possibility to: Take over the role of the participant for an active substance/product-type combination (see Annex II, part 2 of regulation No 1062/2014): - when previous participants have withdrawn - when the identity of an active substance has been redefined 1 Article 14 is explained in section When must you notify? 2 Article 15 is explained in section When must you notify? 3 Article 16, relating to article 15, is explained in section When can we apply for this inclusion in the review Programme? 4 Article 17 is explained in section What is a notification? 04.11.2014 EcoMundo Page 2
include an active substance in the new Review Programme when this substance has not been approved or included in the old programme for the PT concerned If you are interested in any of these, then you must act now by submitting a notification to ECHA. The Commission will give its decision of non-approval for any active substance/product-type combination listed in Regulation No 1062/2014 (Annex II, part 2), for which no notification will have been submitted until 30 October 2015 (or if the notification is rejected). Guidance is currently in progress and will be available before the end of the year 2014. What is a notification? It is a submission to ECHA, subject to a fee of 10,000 Euros, but reimbursed after submission of the application for the approval of an active substance. Information requirements - very limited and similar to the notification process under the BPD Review Programme - are specified in Annex I: Prepare a dossier in IUCLID and submit it via R4BP Show evidence that it is an existing active substance, i.e. present on the EU market before 14 May 2000 for biocidal purposes Include information on the applicant, the substance s identity and intended use Compliance is verified by ECHA with the possibility of appeal against the decisions rendered, if required. When can we apply for this inclusion in the review Programme? When a biocidal product placed on the market is composed of an existing active substance, which is not approved, or listed in Annex I of the Regulation, or included in the Review Programme for the product-type concerned, the substance can be included in the Review Programme for the producttype concerned for one of the following reasons: The biocidal product placed on the market was initially considered to be outside the scope of the BPD or BPR but this is no longer the case today - for example, flocculants used to remove algae from ponds were, until the BPR, outside the scope of the directive The substance benefited from a derogation for food and feedstuffs (used as attractant or repellent under the old Review Regulation) - a notification must be submitted in order to check if the derogation still applies) Due to the modification of a product-type s scope under the BPR, your active substance is not included in the Review Programme for this new product-type - for example, algaecides, which were used for the preservation of construction materials, moved from product-type 10 to 2 (in this case, the notification has to be submitted to the Commission) Anyone concerned with the above cases mush therefore submit a declaration of interest to notify, then, after ECHA s approval and the publication of the invitation to notify, the notification must be submitted. 04.11.2014 EcoMundo Page 3
6 mois 2 ans Submission of a declaration of interest before the Commission or ECHA Acceptance of the declaration by the Commission or ECHA Publication: invitation to send a notification (ECHA) Notification to ECHA Verification of the notofication's compliance by ECHA Submission of a dossier for AS approval or for inclusion in Annex I Process of inclusion in review programme The submission of declaration of interest has to be notified to the Agency (ECHA) for food and feedstuffs derogations or to the Commission for other processes. Therefore, if you have a food and feedstuffs derogation under the old Review Regulation or are affected by the change in scope of a product-type under the BPR, you have to act now by submitting a declaration of interest to notify to either ECHA or the Commission. Indeed, you only have one year to submit your interest to notify otherwise this type of product will be illegal on the market. All the instructions explaining how to submit your declarations of interests (via a web form) or your notifications (via R4BP), will be available on ECHA s website before the end of this year. All other processes described in the Review Regulation - such as withdrawal and taking over the role of the participant - will be done through web forms. Instructions concerning these procedures will soon be available on ECHA s website. IT tools The current versions of the IT tools are R4BP 3.1.2 and IUCLID 5.6. R4BP3 Released on 3 December 2014, this tool is important for companies using it to submit their applications. For Member States, it is a communications tool but also a means to collect and store SPCs. This tool facilitates benchmarking on the EU market. Here is a list of some of the new features: Possibility to check your SME status Export the data of your submission onto your local system with the possibility to filter data before the export Printing of the case details Regrouping submissions: for example, before, to apply for Mutual Recognition, you had to do it by member state. In the next version of the R4BP, all you will have to do is select all the member states in which you wish to apply for MR and submit the application in one step. Implementing email alerts: you will receive an email every time information concerning your ongoing procedures arrives on your account. However, you still have a legal obligation to regularly connect to your account to see if new information has been sent to you. Possibility to nominate consultants in the system Possibility to manually transfer an authorisation from a company A to a company B 04.11.2014 EcoMundo Page 4
SPC editor Summary of Product Characteristics - Release in October 2014 From December, a new SPC will be required for new biocidal product authorisation applications (but not for renewal applications). For the moment, the SPC used is the one available on the ECHA s website (word document). For on-going applications, ECHA will create a new SPC for you. But for new Union authorisation applications, SPC will have a new structure that benefits both ECHA and applicants. Thus, ECHA will provide you with a tool to help you draft your SPC: the SPC editor Launched in October 2014, this new tool helps companies to carry out their duties properly under BPR when submitting their National as well as European authorisation application. The application is available on internet, but the integration of data is via our system in order to guarantee confidentiality. No data will be put online. This tool is entirely compatible with the new 3.2 version of R4BP. Some data entered in the SPC Editor, needed for biocidal product authorisation applications, will be directly integrated in R4BP to avoid entering the same information twice. The SPC Editor drafts SPCs for products alone as well as for families of products. Moreover, it will allow SPC translation into all EU languages including Norwegian. Finally, the SPC can be printed. Be careful, the tool is only available on IE10 + Mozilla Firefox 29+ and Google chrome 35+. If you have already started working on your SPC via word, then you can copy/paste your data into the SPC Editor. IUCLID IUCLID is a mandatory format because it is the best way to communicate data to competent authorities and to the Agency (well structured, possibility to process the data further, no need to print). Technical upgrades are still ongoing: IUCLID 6 will be available for submissions to ECHA from 2016. Among the new features: you will be able to install it simply, it opens the possibility to customize your user interface and the help system will be enhanced. Treated articles Concerning restrictions, it has been confirmed that restrictions will be maintained for the use of an active substance in an article if the substance presents an identified danger. According to article 58 (3), labelling is sometimes required, particularly when the active substance has been approved for some uses and not others, or if the substance is of very high concern (for example if it is classified as a skin sensitizer cat.1a/1). In this last case, the company must assess exposures to the substance in order to determine if this specific label is relevant. For complex articles, a mutual agreement was reached. The following example was given: if paint has been treated with a preservative (in-can preservative PT 6) and that this paint is used to paint part of some furniture, then this furniture will not be considered as a treated article because the preservative does not have any expected function on the final article. The next decisions and assessments will be made along this rule. With experience, authorities will decide if it is relevant to come back on this rule or not. Authorities are also reflecting on the sustainable use concept. Some companies are currently consulted to give their opinion on the following questions: 04.11.2014 EcoMundo Page 5
How do you promote products with a better profile for the environment and public health? Answer elements: with a specific labelling or a logo on such products. For example for those that are eligible for the simplified authorisation procedure. How do you follow uses? Answer elements: by annually declaring via R4BP, the quantities of substance or biocidal products placed on the EU market. How do you promote the best practices to inform the final users on the risk and risk management measures? As previously stated, discussions are ongoing. A report will be submitted to the council and Parliament to amend the Regulation. According to M. Choraine (DG Environment, European Commission), the key points and objectives on the short or medium term would be to finish the active substance assessments according to the Review Programme, finish authorising or not all the products for which a Union authorisation application was submitted and finally, think about how to improve the use of biocidal products. The end of this year will be highly eventful, particularly with the implementation of a new Review Programme, the notifications to submit, the launch of the SPC Editor and even of R4BP3.2. However, discussions are still ongoing concerning the notion of treated articles or even families of products. Nevertheless, EcoMundo will be following this closely to always keep you informed on the latest regulation amendments and evolutions that can impact your affairs. By Margaux Tanguy and Aurélie Lemétais Regulatory project leaders at EcoMundo 04.11.2014 EcoMundo Page 6
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References Internet documents ECHA, forthcoming revision of the fee regulation and national fees, relevant policy issues, Pierre Choraine. URL: http://echa.europa.eu/documents/10162/21743569/03_bshd_choraine_commission_en.pdf ECHA, new review programme regulation, Erik Vandeplassche. URL:http://echa.europa.eu/documents/10162/21743569/06_bshd_vandeplassche_echa_en.pdf ECHA, new summary product characteristic (SPC) editor for biocides authorization URL:http://echa.europa.eu/view-article/-/journal_content/title/new-summary-product-characteristiceditor-for-biocides-authorisation ECHA, IT tools Biocides stakeholders day, Jan Weber. URL:http://echa.europa.eu/documents/10162/21743569/07_bshd_weber_echa_en.pdf Health and Safety Executive, Derogation for foodstuff based repellents and attractants. URL:http://www.hse.gov.uk/biocides/derogation.htm 04.11.2014 EcoMundo Page 8