BPR in Brief. Guidance Document for A.I.S.E. members

Transcription

1 BPR in Brief Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Guidance Document for A.I.S.E. members Version November2013

2 This document has been prepared by A.I.S.E. with all possible care and based on the most recent available information. It is provided for members use. A.I.S.E. cannot accept any responsibility or liability and does not provide a warranty for any use or interpretation of this document The document will be subject to adaptation and refinement due to the forthcoming amendments to the Regulation and through experience gained following the practical operation and implementation of the new legislative instrument. 1

3 Contents 1. The Biocidal products Regulation - What is it? What is the scope of BPR? What is a biocidal product (family) & treated article in the meaning of BPR? BPD vs. BPR what has changed and what is new? Which Biocidal Product Types are covered by BPR? Which are the Product Types most relevant to A.I.S.E. members (BPD vs. BPR)? When does it come into force? Who does it apply to? Have any other of the definitions changed under BPR? When do I need to comply with it? When do I need to submit my product authorisation application? What is new in Biocidal Products Regulation (BPR vs. BPD) (non-exhaustive list)? How do Treated Articles and labelling requirements affect A.I.S.E. members (detergents)? What are the label elements required if my treated article meets the above labelling criteria Which claims on treated articles may indicate primary biocidal function of a treated article (treated article vs. biocidal products)? Is Annex I of the EU Biocides Regulation the same as Annex I of the BPD? What do I need to do in preparation for BPR as a biocidal product formulator? What is the Changes Regulation and what type of changes can I apply to my authorised biocidal products? Can I group proposed changes when applying for a change to my Biocidal Product? What is the Same Products Regulation and which conditions I need to meet to apply for it? What should I include in my application for authorisation of the same biocidal product? How to prove that my product is the same as a reference biocidal product? How former BPD tasks will be managed by ECHA (tasks mapping)? What Implementing Regulations are available in support of BPR? What guidance is available? Useful links

4 1. The Biocidal products Regulation - What is it? Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. The objective of the new Regulation is to improve the internal functioning of the internal market for biocidal products, whilst aiming to provide a high level of protection for humans, animals and the environment. It came into force on 1 st September 2013 and it replaces and repeals The Biocidal Products Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning placing of biocidal products on the market (commonly referred to as the BPD Directive or BPD ). This Regulation (commonly referred to as the BP Regulation or BPR ) harmonises rules on making biocidal products available on the market and their use through outlining criteria for: 1. establishing a European list of approved active substances which may be used in biocidal products, 2. the authorisation of biocidal products, mutual recognition of authorisation within the Union, making available on the market and the use of biocidal products (within one or more MS of the Union), 3. placing on the market of treated articles, 4. a new simplified authorisation procedures (Annex I, parallel trade permit, same products authorisation, etc.) The BPR will bring in some changes in relation to the Regulation of biocidal products, but the basic mechanics of requiring assessment of the active for efficacy and safety for humans and the environment, followed by authorisation of biocidal products containing that active(s) remain the same as for the BPD. In addition, BPR is supported by a number secondary I pieces of legislation that have been adopted including: Same Products Regulation Changes Regulation Fee payable to ECHA Regulation Regulation extending the duration of the review programme for existing biocidal active substances Commission Regulation (EU) No 613/2013 amending Regulation (EC) No 1451/2007 as regards additional active substances of biocidal products to be examined under the review Programme Regulation adding proof of technical equivalence as an information requirement for product authorisation Other supporting secondary legislation is also in preparation You will find more information on these legislative instruments in questions: 19, 21 and 22 Please note that currently Regulation (EU) No 528/2012 is being reviewed. This guidance document does not reflect proposed changes and provides information based on the BPR text which is presently in force (November 2013). 3

5 2. What is the scope of BPR? All the product types that were previously included under the BPD are within the scope of the Biocidal Products Regulation with the exception of preservatives for food and feedstock (Product type 20 under the BPD) which have been removed as such preservatives are covered by other EU legislation. N.B Some descriptions of Products types have also been changed or expanded compared to the BPD In Situ biocides, both those generated from supplied precursors and those where no precursor is supplied, are now clearly in scope of the new Regulation. The Biocidal Products Regulation also makes it clear that the review of an existing active substance will only cover nano forms if data has been submitted on those nano-materials. BPR applies to biocidal products 1 products) that are regulated as: and treated articles, with exception for products (non-dual use Food or feed used as repellents or attractants Biocidal products when used as processing aids Medicated feedingstuffs as defined and covered in Directive 90/167/EEC Medical devices (including implantable and invitro diagnostic medical devices) as defined and covered by Directives: 93/42/EEC; 90/385/EEC; 98/79/EC Veterinary medical products as defined and covered by Directive 2001/82/EC Medicinal products for human and veterinary use as defined and covered by Directive /EC and Regulation (EC) No 726/2004 Plant Protection Products as defined and covered in Regulation (EC) No 1107/2009 Cosmetic products and in-can preservatives for cosmetics products as defined and covered by Regulation (EC) No 1223/2009 on cosmetic products Please note: that biocidal products and treated articles falling within the scope of the above instruments but intended to be used for the purposes not covered by the above legislation should be regulated via Biocidal Products Regulation. E.g. A product marketed as a sunscreen and repellent might be in some cases regulated as a dual use product. Such a product may potentially be regulated via Cosmetics Regulation for its sunscreen function and via BPR for its repellent purpose. 3. What is a biocidal product (family) & treated article in the meaning of BPR? Biocidal Product is defined as any substance or a mixture, including in-situ generated active substances and mixtures, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. 1 including biocidal substances or mixtures generated in-situ 4

6 In addition, the biocidal product definition covers situations where a substance or a mixture, generated from a substance or mixture not covered by the first intent is used with the purpose of destroying deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action E.g. A surface disinfectant with a biocidal claim (proven by efficacy data) containing Sodium Hypochlorite E.g. The combination of TAED and Sodium Percarbonate forming Peracetic Acid for chemical disinfection (product intended to be sold as a biocide carrying a biocidal claim) E.g. (Second intent) Generation of Sodium Hypochlorite on site and used for the disinfection of the premises. Biocidal Product Family The concept of Biocidal Product Family is new in BPR. Biocidal product family is defined as a group of biocidal products having similar uses, same active substances of the same specifications and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products. Biocidal products within a family may exhibit variation in their composition with regards to percentage of one or more active substances and/or non-active substances. Furthermore, replacement of one or more non-active substances by other ingredients presenting the same or lower risk is possible. However, the specified variations within the family should not adversely affect the level of risk or efficacy of the products. A biocidal product family may be authorised via a centralised or national procedure. This new concept is broader than the BPD Frame Formulation application. Once a Biocidal Product Family is authorised, an applicant may add an additional product to the family portfolio, beyond those already specified in the dossier. However, to do so, a specific notification has to be forwarded to each competent authority (ECHA or the Commission where relevant) which has granted authorisation of the initial family. Each additional product has to be notified at least 30 days before placing on the market (except where a product is explicitly identified in the first authorisation dossier or the variation in composition concerns only pigments, perfumes and dyes, all within the permitted variations). The notification content: - exact composition - trade name - suffix to the authorisation number Please note that the classification, hazard and precautionary statements for each product within the biocidal product family shall be the same (with the exception of a biocidal product family comprising a concentrate for professional use and ready-for-use products obtained through dilution of that concentrate). E.g. A surface disinfectant with a biocidal claim (proven by efficacy data) containing Sodium Hypochlorite but available in 5 different colours and containing different types of surfactants (within the identified family ranges). All these variations are identified and covered by one dossier. 5

7 Treated Article is defined as any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products. A treated article that has a primary biocidal function shall be considered a biocidal product. Examples of treated articles: E.g. An all-purpose cleaner containing an active substance acting as an in-can preservative (PT6) E.g. Preserved packaging material which has been treated with an active substance/a biocidal product (PT7) Example of treated article with primary biocidal function: E.g. A mosquito net treated with a repellent biocidal product 4. BPD vs. BPR what has changed and what is new? BPD 98/8/EC BPR (EU) No 528/2012 (Until 31. August 2013) (since 1 September 2013) Approval of Active substances at EU level National Authorisation of Biocidal Products with mutual recognition Data requirements for applications Transitional measures for a biocidal product during its active substance review Exclusion of cleaning products that are not intended to have a biocidal effect BPD BPR Annex I-inclusion Approval Annex I List of approved substances Annex IA Annex I Low- risk products Simplified procedure Frame Formulation Biocidal Product Family Comparative assessment of AS Comparative assessment of BP BPD 5. Which Biocidal Product Types are covered by BPR? BPR Union Authorisation of BP Hazard Based exclusion & substitution criteria Mutual Recognition procedures (parallel, sequence) Harmonised SPC Treated Articles Mandatory data sharing & List of approved suppliers New role of the Agency (ECHA) New IT tool = obligation to use IUCLID All product types which were previously covered by BPD are within the scope of BPR with the exception of preservatives for food and feedstock (former product type 20). This product type has been removed from the scope and is covered by other EU legislation. Please note that in addition, some descriptions of Product Types have been changed or expanded compared to those descriptors used in the old BPD. BPR covers 22 biocidal product types. These can be found in Annex V of BPR and include: 6

8 Main group 1: Disinfectants Main group 2: Preservatives Main group 3: Pest Control Main group 4: Other biocidal products Note: Annex V clarifies that cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products are excluded from the provision of the BPR regarding biocidal products. 6. Which are the Product Types most relevant to A.I.S.E. members (BPD vs. BPR)? PT BPD BPR PT1 Human hygiene biocidal products Human Hygiene PT2 Private area and public health area disinfectants and other biocidal products Disinfectants and algaecides not intended for direct application to humans or animals PT3 Veterinary hygiene biocidal products Veterinary Hygiene PT4 Food and feed area disinfectants Food and feed area PT6 In-can preservatives Preservatives for products during storage PT18 Insecticides, acaricides and products to control other arthropods PT19 Repellents and attractants Repellents and attractants Insecticides, acaricides and products to control other arthropods 7. When does it come into force? The biocidal products regulation was adopted on the 22nd May 2012 and came into force 20 days later. It repeals and replaces Directive 98/8/EC as of 1st September Important notice: There is an on-going partial revision of the Regulation (EU) No 528/2012 which concerns. Specific provisions including transitional measures concerning treated articles (Art.94) and transitional measurements for biocidal products already placed on the market (Art.89 (4)). It is expected that the revised text of the Biocidal Products Regulation will come into force in the first quarter of Who does it apply to? BPR applies to any person established within the Union who is responsible for placing active substances, biocidal products or treated articles, on the market. It also covers the use of biocidal products. a) Manufacturers of active substances and formulators of biocidal products, including importers, must ensure that these are approved (active substances) or authorised (biocidal products) before being first made available on the market (transitional measures according to Art.89 are applicable). b) Manufacturers and importers of treated articles must make sure that all active substances contained in the biocidal products (used for treatment of the articles or incorporated into the articles) are included in the Union List for the relevant product-type and use, or in BPR Annex I, and any conditions or restrictions specified therein are met (transitional measures according to Art.94 are applicable). 7

9 Please see the graph below to better understand obligations of BPR actors: 9. Have any other of the definitions changed under BPR? Yes, there has been change to a number of BPD definitions. Making available on the market is defined as any supply of a biocidal product or treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge. Placing on the market is defined as the first making available on the market of a biocidal product or treated article. Use is defined as all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union. Treated Article is defined as any substance, mixture or article which has been treated with, or intentionally incorporates one or more biocidal products Details of all the definitions in the BPR are given in Article When do I need to comply with it? As of the 1 st September 2013, but in light of the on-going review program under the BPD, the below transitional provisions apply under BPR. 8

10 Biocidal Products Manufacturers of Biocidal Products for which the active substance(s) are still in the evaluation process (Review process) may continue to make these biocidal products available on the market according to national schemes. As of 1 st September 2013 Manufacturers of Biocidal Products authorised under BPD 98/8/EC may continue to make biocidal products available on the market, subject to any conditions of authorisation or registration stipulated under Directive 98/8/ EC until the expiry date of authorisation or cancellation of registration. Biocidal Products under evaluation according to BPD 98/8/EC for which authorisation has not been granted by 1 st September 2013 shall be evaluated under Directive 98/8/EC unless, the biocidal product contains an active substance meeting exclusion criteria or being a candidate for substitution. In these cases the BPR authorisation rules shall apply. By 1 st September 2017 Manufacturers of Biocidal Products not covered by the scope of Directive 98/8/EC but falling within the scope of BPR and which were available on the market on the 1 st of September 2013 shall submit an application for authorisation of the biocidal product. E.g. Ozone generated in-situ E.g. CO 2 generated through combustion of butane or propane Treated Articles By 1 st September 2016 Manufacturers of treated articles that have been available on the market on the 1 st September may continue making available on the market these treated articles, until the date of a decision concerning the approval for the relevant product-type of the active substance(s) contained in the biocidal products with which the treated articles were treated or which they incorporate. These treated articles may also continue to be placed on the market if the application for the approval of the active substance(s) for the relevant producttype is submitted at the latest by 1 September List of active substance suppliers As of 1 st September 2015 Formulators of a biocidal product must ensure that they purchase active substances from sources of active substances (manufacturers/importer) included on the ECHA list of approved suppliers. This list includes participants of the review programme where the evaluation process has been positively concluded or is still on-going. Importers of a biocidal product must enter the list of active substances suppliers for an active substance they are importing. This can be done via a Letter of Access from a manufacturer already listed or by submitting a dossier for an equivalent active substance. 11. When do I need to submit my product authorisation application? In accordance with BPR practices, applications for the authorisation of a biocidal product must be submitted, at the latest, on the approval date of the relevant active substance (under BPD in practice approximately 24 months after the decision on approval). However, with changes in the review 9

11 programme this period can be shorter for certain active substances and be equal to approximately months after the decision on approval of the last active substance for the relevant PT. A biocidal product can stay on the market subject to national rules if all existing active substances it contains are in the review programme for the relevant product type. Please note that after 1 st September 2015 a biocidal product can only stay on the market if all suppliers of the active substances incorporated in the product are listed on the list of alternative suppliers (Art. 95). The disposal and use of existing stocks of biocidal products containing active substances, for which no relevant person is included in the list of alternative suppliers, may continue until the 1 st of September a. What type of Authorisation are available under the Biocidal product Regulations? The BPR allows for more types of authorisation that were available under the Biocidal Products Directive; these include National Authorisations Union Authorisations Mutual Recognition in sequence or in parallel Simplified Authorisations Biocidal Product family Authorisations Same Products Authorisations Parallel Trade Permits Research Permits 12. What is new in Biocidal Products Regulation (BPR vs. BPD) (non-exhaustive list)? BPR introduces number of new elements into the practice of authorising biocidal active substances and biocidal products in the EU. Main Changes in terminology include: BPD BPR Annex I inclusion Approval Annex I List of approved substances Union List Annex IA Annex I Low risk products Products eligible for the simplified procedure Frame Formulation Biocidal Product Family Phase out Grace Period Completeness check Validation 2 Please note that this is a generic example. It is advised to monitor review of active substances on a case by case basis. In some cases time to prepare and submit product dossier can be shortened to 20 months. 10

12 New elements include: Union Authorisation of biocidal products One of the main additions under BPR is the authorisation of biocidal products via the Union Authorisation procedure (commonly referred to as UA ). The Union Authorisation process is coordinated by the European Chemicals Agency (ECHA) and once granted it allows placing a product on the market in all MS, with no need to apply for neither National Authorisation nor Mutual Recognition (with the possibility for MS to restrict the use of the product in justified cases). Union Authorisation is available for biocidal products having similar conditions of use across the EU and not containing active substances meeting the exclusion criteria. In addition, biocidal product types: 14,15,17,20 and 21 are restricted from applying for UA. Timelines for Union Authorisation: - From 1 September 2013 for product-types 1, 3, 4, 5, 18 and 19 - From 1 January 2017 for product-types 2, 6 and 13 - From 1 January 2020 onwards to the remaining product- types 7, 8, 9, 10, 11, 12, 16 and 22. Hazard based exclusion and substitution criteria BPR sets hazard based conditions under which an active substances meeting the following criteria cannot be approved: - classified or which meet the criteria to be classified as Carcinogen category 1A or 1B - classified or which meet the criteria to be classified as Mutagen category 1A or 1B - classified or which meet the criteria to be classifies as, Toxic for reproduction category 1A or 1B - to be considered as having endocrine-disrupting properties 3 - which meet the for being PBT or vpvb Mutual Recognition in parallel & sequence BPR provides the opportunity for a biocidal product formulator to apply for Mutual Recognition of National authorisation in parallel (when the national authorisation process is still on-going) or in sequence (as soon as the first authorisation has been granted by Reference Member State). Summary of the biocidal product characteristics (SPC) Under BPR, SPC becomes a part of the biocidal product authorisation. Art.22 of BPR introduces an extensive list of elements that should be included in every summary of biocidal product characteristics. From the date on which a biocidal product is authorised, the Agency will make this document publicly available. Treated Articles according to BPR rules articles, mixtures or substances may be treated with or incorporate only EU authorised biocidal products. This is also valid for imported treated articles, which should be treated with or incorporate only EU approved active substances (BPR foresees transitional measures for articles treated with or incorporating biocidal products containing active substances under evaluation). Additionally new labelling requirements will apply to some of the treated articles. Mandatory data sharing Under the BPR rules, data sharing (vertebrate animal studies) becomes mandatory. Data sharing should involve equitable compensation. 3 At this stage there are no official criteria for ED properties. However some classifications are consider as ED by default. 11

13 New Role of the Agency (ECHA) - Biocidal Products Regulation grants the responsibility for the technical and scientific tasks relevant to this centralised system (UA) to the European Chemical Agency (ECHA). Moreover, as of the 1 st of September 2013 ECHA is responsible for coordinating active substances evaluation; including the Union list of approved active substances. Simplified Authorisation - The new Regulation establishes rules under which biocidal products containing low-risk active substances can be authorised via a simplified procedure. Annex I of BPR lists active substances for which biocidal products can profit from an authorisation based on a limited data package. Please note that specific restrictions apply to biocidal products containing active substances included in the Annex I listing How do Treated Articles and labelling requirements affect A.I.S.E. members (detergents)? BPR introduces new requirements concerning treated articles, including labelling requirements. Detergents that are a treated article in the meaning of BPR ( substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products ) should comply with Article 58 of BPR, as well as transitional measures set by Article.94. This concerns for example regular liquid detergents that do not qualify as a biocidal product but contain biocidal active substances or biocidal products such as in-can preservatives. According to Article 58(2), such in-can preservatives must be listed in the future Union list of approved active substances (former Annex I and IA of BPD). Transitional measures for in-can preservatives which are still in the review program shall apply according to Art.94 (see question 10). Labelling of treated articles : According to Art.58 (3) of BPR, specific labelling requirements (see Question 14) (e.g. detergent] are required for the treated article if: A claim is made regarding the biocidal properties of the treated article [e.g. detergent], or Labelling is required under the conditions associated with the approval of the active substance [e.g. preservative] contained in the treated article [e.g. detergent]. If neither of these two conditions are met, the treated article [e.g. detergent] does not need to be labelled under BPR. In addition, where labelling provisions apply, Art.58 (3) clarifies that such labelling shall not apply where at least equivalent labelling requirements already exist under sector-specific legislation for biocidal products in treated articles to meet information requirements concerning those active substances contained in the treated articles. Annex VII of the Detergents Regulation requires labelling of preservatives, if added, irrespective of their concentration, using where possible their INCI names. Therefore, if one of the two conditions above is met, e.g. in the case of preservatives, the detergent manufacturer should assess whether the labelling mandated by the Detergents Regulation is at least equivalent. This concerns detergents sold to the general public. 4 For example: For some of the active substances listed in Annex I, concentration of active substance in a product needs to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/

14 IMPORTANT: Currently I&I products provide information on in-can preservatives on the SDS sold with the product. In case any of the conditions specified above are met, the presence of an in-can preservative would have to be labelled on the pack in order to qualify as at least equivalent. 14. What are the label elements required if my treated article meets the above labelling criteria The label of a treated article shall provide the following information: a) a statement that the treated article incorporates biocidal products b) where substantiated, the biocidal property attributed to the treated article c) the name of all active substances contained in the biocidal products d) the name of all nanomaterials contained in the biocidal products, followed by the word nano in brackets e) any relevant instructions for use, including any precautions to be taken because of the biocidal product with which a treated article was treated or which it incorporates Moreover, suppliers of a treated article shall, when a consumer requests, provide that consumer, within 45 days, free of charge, information on the biocidal treatment of the treated article. The main requirements for labelling of treated articles are set out In Article 58 (3) but additional labelling provisions are set out in Art 58 (4); and (6) 15. Which claims on treated articles may indicate primary biocidal function of a treated article (treated article vs. biocidal products)? The Guidance Document on Treated Articles (see Q 25) developed in the support of BPR lays down a number of criteria to determine whether the biocidal function of a treated article is 'primary'. One of the criteria is a claim (including claim with public health relevance) and its prominence. However, claims on a given treated article need to be considered, together with all other individual properties and functions and the intended uses of that article, before the decision as to whether the treated article may have a primary biocidal function is taken. Examples of claims indicating possible primary biocidal function of the treated article: Claims that a treated article would protect users or others against specific pathogenic bacteria, viruses, fungi or other organisms such as E. coli, S. aureus, Salmonella sp., Streptococcus sp., influenza H1N1 virus, and diseases vectors, such as ticks or mosquitoes. Antibacterial Fight germs Kills 99% of bacteria Provide antibacterial protection Control fungus 13

15 16. Is Annex I of the EU Biocides Regulation the same as Annex I of the BPD? No, Annex I of the EU Biocides Regulation is the list of active substances that can be used in product that qualify for a simplified authorisation procedure (see question 12). Currently, Annex I includes 21 substances, some of them were already included into the Annex IA of the BPD. The active substances currently listed in Annex I of the BPD will be included in the Union list of approved active substances (Art.9) that will be available electronically on the ECHA website. 17. What do I need to do in preparation for BPR as a biocidal product formulator? In light of the Biocidal Products Regulation provisions, it is advised to: Make sure that you stay legal on the market (either under the transitional measures or according to new BPR rules) Check which products of the company s portfolio fulfil the criteria of a biocidal product: Read carefully the definitions of a biocidal product and treated article (see question 3) Check which active substances are used in your biocidal products and for which product type Check if suppliers of active substances contained in the biocidal products are listed as Alternative suppliers (Art.95 (2)) for the relevant product type. Remember: as of the 1 st of September 2015, a biocidal product shall not be made available on the market if the manufacturer or importer of the active substance(s) contained in the product is not included in the list (products covered by the transitional measures are also affected). If your supplier is not yet listed on the provisional ECHA List of Alternative suppliers (or product type of your interest is not supported) it is advised to enquire for clarification. If your company generates biocidal active substances in-situ (e.g. peracetic acid) you need to monitor developments of the Commission with regards to in-situ generated active substances and its precursors (at this stage it is unclear which transitional measures apply to in-situ generation) Check regularly the active substance review status (Q11) If a decision is made to not approve an active substance for a PT of your interest, follow the appropriate phase-out periods for the disposal and use of existing stocks of relevant biocidal products Monitor any plans with regards to the potential extension of the review programme Check if the active substances of your interest would meet the exclusion or substitution criteria Consider applying under the Biocidal Product Family concept Compare possible routes of authorising your products (Union vs. National) Start work on the product dossier as soon as possible! Check if mixtures or articles you produce/market do not fall under the definition of treated article. Please note that this includes non-biocidal chemical products (e.g. detergents) If your portfolio contains biocidal products (active substances) not previously covered by BPD remember that the deadline for application for authorisation concerning these products is the 1 st of September If an active substance of your interest has been identified as a candidate for substitution consider contributing to the public consultation phase 14

16 18. What is the Changes Regulation 5 and what type of changes can I apply to my authorised biocidal products? The Changes Regulation lays down provisions concerning any changes to initial biocidal products/family authorisation application. Changes regulation classifies changes into three categories; these can be found in the Annex of the regulation: Administrative change Minor Change Major change In case of any doubt with regards to classification of a planned change, authorisation holders may request the Agency for an opinion. After receiving the request and proof that the fee has been paid the Agency has 45 days to deliver an opinion on the classification of the change Currently, under the Fees Regulation, a fee of 2000 has to be paid in advance to classify a change (please consult Annex of Fees Regulation for any possible updates 6 ) 19. Can I group proposed changes when applying for a change to my Biocidal Product? Under the Changes Regulation each change should be requested via individual notification. However, in some cases, in order to limit the administrative burden, it is possible to group changes (a single notification covering series of proposed changes). These situations include: a series of proposed administrative changes affecting different products in the same manner a series of proposed administrative changes affecting the same product In the case of multiple changes to the same biocidal product issuing group notification is possible if: one of the proposed changes in the group is a major change to the product and all other proposed changes in the group are a direct consequence of that change one of the proposed changes in the group is a minor change and all other proposed changes in the group are a direct consequence of that change all changes in the group are a direct consequence of a new classification of the active substance(s) or non- active substance(s) contained in the product or of the product itself all changes in the group are a direct consequence of a specific condition of the authorisation 5 Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

17 20. What is the Same Products Regulation 7 and which conditions I need to meet to apply for it? The Same Products Regulation is one of the BPR implementing regulations. It lays down rules for the authorisation of biocidal products/biocidal product families identical to those already authorised 8. To apply for the Same Products Authorisation below conditions should be met: Biocidal products or families which want to profit from this procedure should be identical to products already authorised. Some adaptations to the product are possible however; these should be limited to purely administrative changes, as described in the Changes Regulation. Possible administrative changes, including but not limited to, as described in the Changes Regulation 9 : Name of the biocidal product Changes of the name of the biocidal product where there is no risk of confusion with the names of other biocidal products. Addition of a name for the biocidal product where there is no risk of confusion with the names of other biocidal products. Authorisation holder Transfer of the authorisation to a new holder established in the European Economic Area (EEA). Change in the name or address of the authorisation holder, which remains in the EEA. Change in other administrative details of the authorisation holder than the name and address. Manufacturer(s) of the active substance(s) Addition of a manufacturer of the active substance or change in the manufacturer s identity or in manufacturing location or process, where the technical equivalence between the substances from the two manufacturers, manufacturing locations and processes has been established by the Agency in accordance with Art.54 of Regulation (EU) No 528/2012, and the manufacturer or importer is listed in accordance with Art.95 (2) of Regulation (EU) No 528/2012. Biocidal product family Authorisation as a biocidal product family of a number of authorised products falling within the specifications of a frame-formulation established in accordance with Directive 98/8/EC in accordance with the same terms and conditions. Formulator(s) of the biocidal product Manufacturer(s) of the active substance(s) Change in the name, the administrative details or the formulating location of the biocidal product formulator, where the biocidal product composition and the formulating process remain unchanged. Deletion of a formulating location or a formulator of the biocidal product Addition of a formulator of the biocidal product, where the biocidal product composition and the formulating process remain unchanged Change in the name or the administrative details of a manufacturer of the active substance, where the manufacturing location and process remain unchanged and the manufacturer remains listed in accordance with Art.95(2) of Regulation (EU) No 528/2012 Deletion of a manufacturer or a manufacturing location of the active substance Conditions of use More precise instructions for use, where only wording but not content of instructions are changed 7 Commission Implementing Regulation (EU) No 414/2013, specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council 8 Authorised or registered in accordance with Directive 98/8/EC or Regulation (EC) No 528/ Commissions Implementing Regulation (EU) No 354/2013 on changes of biocidal product authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council 16

18 Classification and labelling Removal of a particular claim, such as a specific target organism or a specific use. Removal of a category of users Addition, replacement or modification of a measuring or administration device not relevant for the risk assessment and not regarded as a risk mitigation measure Change to the classification and labelling, where the change is limited to what is necessary to comply with newly applicable requirements of Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 1 ). ( 1 ) OJ L 353, , p. 1. Please note that: ECHA should after consulting the Member States, the Commission and interested parties, draw up guidelines on the details of the various categories of changes of products. 21. What should I include in my application for authorisation of the same biocidal product? Application for the same product authorisation should include following elements: Authorisation number of authorised reference biocidal product/family; if an approval process is still on-going the applicant should provide an application number of the reference product from the Register for Biocidal Products (R4BP) List of all proposed changes to the product and evidence that products are identical on all other aspects. The allowed changes are limited to administrative aspects (see question 19 and Changes Regulation) Where relevant a Letter of Access to data of the reference product dossier A draft summary of the biocidal product characteristic for the same product. An applicant or an authorisation holder, of the reference product, can provide a partially completed draft SPC (Original SPC with site location removed) E.g. Company B buys an identical mixture from company A and changes the package and labelling E.g. Company B buys a technical concentrate + recipe (detail instruction: add solvent up to % etc.)and makes the preparation themself 22. How to prove that my product is the same as a reference biocidal product? In order to prove that your biocidal product is identical to a reference biocidal product the following documents can be used (not exhaustive list): A proof of purchase A proof of supply 23. How former BPD tasks will be managed by ECHA (tasks mapping)? ECHA being a new actor in the process will provide administrative support during the implementation phase of the BPR. This includes the lead role in many new groups (Biocidal Product Committee, Working Groups, and Coordination Group). The graph below presents the new distribution of former BPD tasks under BPR requirements. 17

19 What Implementing Regulations are available in support of BPR? The Commission has drafted a number of implementing regulations in support of the BPR. For updates check the link below: These include: Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and charges payable to the European Chemicals Agency pursuant to 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 Commission Delegated Regulation (EU) No 736/2013 of 17 May 2013 amending Regulation (EU) of the European Parliament and of the Council as regards the duration of the work programme for the examination of existing biocidal active substances 10 Source ECHA 18

20 Commission Regulation (EU) No 613/2013 amending Regulation (EC) No 1451/2007 as regards additional active substances of biocidal products to be examined under the review Programme Commission Delegated Regulation (EU) N0837/2013 of 25 June 2013 amending Annex III to Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the information requirements for authorisation of biocidal products What guidance is available? A number of guidance documents in support of BPR are available. Commission Guidance available Guidance on Fees payable to Member States Dec12-Doc.5.1.b - Final - Note for Guidance on Fees.doc Guidance on Similar conditions of Use Feb13-Doc.5.1.e - Final - Note for Guidance on similar conditions of use.doc Guidance on Borderlines between Biocidal products and Cosmetics borderline cosmetics_biocides.doc Guidance on Treated Articles and Borderlines with Biocidal products a038/CA-Sept13-Doc 5.1.e -Final- treated articles.doc ECHA Guidance available: Guidance on applications for technical equivalence Guidance on information requirements for Biocidal Products Guidance on active substance suppliers Under below link: 19

21 Under the link above you will also find a number of guidance documents prepared for the purpose of BPD. 26. Useful links ECHA DG ENV 20