Zulassung von Biozid-Produkten

Transcription

1 Zulassung von Biozid-Produkten Änderungen durch die EU-Biozid-Produkte-Verordnung Emrah Turudu

2 Overview Biocidal Products Directive Biocidal Products Regulation (draft version March 2012) The two-stage concept active substances/biocidal products - with gross comparison BPD-BPR Conditions, criteria, requirements, procedures EU cooperation, R4BP Remarks on renewal, cancellation or modification of an authorisation As above Significant new features Slide 2

3 EU* two-stage concept stage I active substances BPD Annex I/IA inclusion of AS (positive list of AS which may be used in BP) Applications to CAs of Rapporteur Member States (RMS) Evaluation by Rapporteur Member States (RMS) -> CA Reports (CAR) Community decision procedures EU Inclusion Directives amending the BPD with corresponding AS Assessment Reports (AR) A) AS approval for Union list of authorised ASs 1. Applications to ECHA (validation) 2. EU-MS evaluation -> AR and conclusions by eca to ECHA 3. Committee examination procedure 4. Implementing Act (or COM non-approval decision) B) AS listed in Annex I 1. for simplified authorisation procedure * EU = EEA-MS and Switzerland (CH); EEA-MS and CH cooperate by specific treaties, have no vote in the EC Slide 3

4 EU two-stage concept stage II biocidal products Authorisations/registrations* of BP in national procedures Applications to national CAs (RefMS) for first authorisation Evaluation by RefMS -> PAR and SPC Technical consultations on EU level National first authorisations Mutual recognition of authorisations by ConcMS ( in sequence ) Authorisation of BP - options 1. Application to ECHA for Union authorisation 2. Application to RefMS for national (first) authorisation, and later possibly 3. Applications to ConcMS for mutual recognition in sequence 4. Applications to RefMS and ConcMS CAs for mutual recognition in parallel 5. Applications to ECHA for the simplified procedure, authorisation by RefMS CA Parallel trade permit * Further on for simplification reference is usually made only to Authorisation (Auth) Slide 4

5 AS Key elements of inclusion of AS in Annex I When the risk based on the use of a representative product is acceptable and principle efficacy is proven AS are included (or not) in AS/PT combinations Usually for 10 years; less if subject to a comparative risk assessment The Specific provisions in the Annexes of Inclusion Directives are binding for decisions on biocidal product authorisations The corresponding Assessment Reports (AR) contain detailed guidance for authorisation conditions Slide 5

6 AS Risk and efficacy determine whether an AS is included or not AS in Annex I for use in products with acceptable risk AS in Annex IA for use in low-risk products An AS must not be included in Annex IA if it is Carcinogenic, Mutagenic, toxic for reproduction, sensitising, or is bioaccumulative and does not readily degrade. the principle efficacy of the AS has to be proven This criterion is hampered by lack of hamonised test guidelines; equivocal practice Slide 6

7 EU two-stage concept - AS some remarks new AS cut-off date 14 May 2000 existing AS : BPD Article 16 for transitional measures Work Programme (review) BPD Article 16 (2) ReviewR (EC) No 1451/2007 (5th EU Review Regulation), Annex II AS/PT non-inclusions: 12 months phase-out period for BP AS/PT withdrawals to keep track of the status of AS/PT combinations in the review you are invited to use the flowchart on 56 AS/PT entries in Annex I and 2 AS/PT entries in Annex IA (by ) Slide 7

8 for guidance implementation documents II on CIRCABC Bibliothek/Documents finalised at CA meetings E. g.: CA-July11-Doc.6.2a - Letters of access CA-March07-Doc Post-annex I inclusion procedure CA-May08-Doc TNsG Technical Equivalence etc Slide 8

9 BP Authorisations of BP in national procedures - conditions AS in the BP has to be listed in Annex I(/IA), except in case of a preliminary Auth of new AS the specific provisions for the AS in Annex I(/IA) and AR are fulfilled, and the BP is sufficiently effective has no unacceptable effects on the target organisms has no unacceptable effects itself or by its residues, on human or animal health, directly or indirectly (e. g. drinking water, food, feed, indoor air), or on surface water and groundwater has no unacceptable effect itself, or as a result of its residues, on the environment (fate and distribution, e. g. contamination of surface waters; impact on non-target organisms) etc. Slide 9

10 Auth(mR) of BP in the EU I Remarks on existing biocidal products definition (applicable EU wide for each national market): products which have already been placed on the market of the relevant Member State at the date of inclusion of the AS into Annex I/IA Submission of application at the latest at AS inclusion date If more than one AS in the BP, the last of the inclusion dates applies Be aware of the concept of dominant/silent active substances If no application has been submitted phase-out of the BP period determined by national legislation: normally 6 months for placing on the market, plus 6 months for clearing of stocks rules for new biocidal products apply Slide 10

11 Authorisation of a new BP in the EU A new biocidal product containing an AS already included in Annex I may be placed on a national market only after its authorisation has been granted Slide 11

12 Auth(mR)/Reg(mR) in the EU practical terms (guidance docs) First Authorisation/registration in Reference Member State Mutual recognition of authorisation/registration in one or more Concerned Member State(s) practical terms cited Reference Member State / Referenzmitgliedstaat as above in national (not Union) authorisation procedures Member State(s) concerned / betroffene(r) Mitgliedstaat(en) for mutual recognition in national (not Union) authorisation procedures evaluating competent authority / bewertende zuständige Behörde eca denominated for evaluation in a Union authorisation procedure receiving competent authority / befasste zuständige Behörde rca MS CA receiving an application (RefMS or MS concerned) Slide 12

13 EU-wide cooperation R4BP exchange format R4BP Access (by ): R4BP vers.i: R4BP vers.ii: User Guide Obligation to use R4BP for notification of an application and generation of application form PARs and SPCs are accessible to all MS CAs through R4BP important additional roles: Product dossiers in IUCLID format Union authorisations: SPCs acessible in all official EU languages (applicant ECHA/eMS COM) R4BP shall contain terms and conditions of an authorisation Implementing Acts for detailed rules on types of information to be entered Provisions in BPR for the event that R4BP is not operational by Slide 13

14 Formal requirements for an authorisation Application for authorisation shall be made by the person who will be responsible for the first placing on the market of a biocidal product in a particular Member State and shall be to the competent authority of that Member State. Every applicant shall be required to have a permanent office within the Community. Notification of any application via R4BP Applications for authorisation by, or on behalf of, the prospective authorisation holder Possession of the supporting data (active substance(s) and biocidal product) or LoA Payment of charges depends on national requirements Slide 14

15 Formal requirements first authorisation see Slide 15

16 Conditions for an authorisation by mutual recognition First authorisation in another EU* MS The relevant conditions of use are the same The target species is present in harmful quantities No unacceptable tolerance or resistance of the target organism to the BP is demonstrated, or The relevant circumstances of use, such as climate or breeding period of the target species, do not differ significantly from those in the Ref MS Slide 16

17 Formal requirements AuthmR I Step I: four months at the latest before the date in column 5 of the Annex to the Inclusion Directive for the active substance in question Step II, completion of the application: submission within two months after the first authorisation has been granted (see PA&MRFG-May11-Doc.4 - Post-annex I inclusion procedure - final) Slide 17

18 Frame-Formulations I Definition Specifications for a group of biocidal products having the same use and user type contain the same active substance(s) of the same specification(s) in purity, type and concentrations of impurities, compositions must present only variations from a previously authorised BP which do not increase the level of risk or affect efficacy. variations allowed reduction in the percentage of the active substance and/or alteration in percentage composition of one or more non-active substances and/or replacement of one or more pigments, dyes, perfumes by others presenting the same or a lower risk. Slide 18

19 Frame-Formulations II Establishment Member States shall, on request, or may, on their own initiative, and where relevant, establish a frame-formulation Slide 19

20 Frame-Formulations III - requirements Authorisation within a frame-formulation The applicant has to submit information/data that are necessary to proof the specification of the BP within an already established frame-formulation and that the variations fulfill the general conditions (risk, efficacy). The applicant is the authorisation holder of the established frameformulation or is entitled by a LoA The period granted for the authorisation is linked to the period for the established frame-formulation R4BP form for data required on frame formulations Slide 20

21 Auth/Reg and AuthmR/RegmR Authorities procedural deadlines Completeness check Detailed evaluation Auth 3 months 12 (9) months AuthmR 1 month 3 months Reg 15 days 45 days RegmA 15 days 45 days Auth(mR)/Reg(mR) within frame fomulation 15 days 45 days Slide 21

22 The two-step concept Active substances included in Annex I with exposure scenario of a representative product 22 Slide 22

23 Charges regulated on MS level regulated by COM and on MS level for provided services fees payable to ECHA, including an annual fee, fees payable to MS, MS annual fees allowed with respect to BP on their markets, ECHA and MS may collect fees for other services they provide, Commission guidance concerning a harmonised structure of fees. Slide 23

24 Charges in AT based on In AT BiozidG-Ordinances on Mandatory Fees Tariffs concept according to complexity in three parts (administration/ad, completeness check/cc, detailed evaluation/ev) AD+CC fees are due prior to submission of application Payment of charges (AD+CC) is part of the application AD+CC fees are refunded if the application is not acceptable for unlawfulness EV fee is due after dossier completeness has been confirmed Slide 24

25 New information The holder of an authorisation for a BP shall immediately notify the CA of any information concerning an AS or a BP which may affect continuing authorisation. MSs shall immediately notify other MSs and COM on receipt of such information Slide 25

26 Cancellation or modification of an authorisation Cancellation if the active substance is no longer included in Annex I or IA the conditions for obtaining authorisation are no longer satisfied false or misleading particulars have been supplied the authorisation holder so requests Modification if a Member State considers it necessary the authorisation holder so requests Slide 26

27 Slide 27

28 AS Key elements for approval to include an AS in the Union list if at least one biocidal product containing that active substance may be expected to meet the criteria in Art. 19 (1)( b) including consideration in Art. 19 (2), i.a. possible cumulative and synergistic effects the BP is sufficiently effective, etc. (see Art. (1)(b)) AS are included (or not) in AS/PT combinations For < 10* y (Art. 4 (1)) or candidates for substitution < 5/7# y (Art. 5 (2)) renewal: *15 y (unless ; Art. 12 (3)) - #7 y Approval does not cover nanomaterials except where explicitly mentioned The Union list approval conditions in implementing Regulations are binding for decisions on biocidal product authorisations The corresponding Assessment Reports (AR) contain detailed guidance for authorisation conditions Slide 28

29 AS (Art. 5) An AS must not be approved (Art. 5 (1)) if it is a carcinogen, mutagen or toxic for reproduction category 1A or 1B, has endocrine disrupting properties (transitional definition), is PBT or vpvb, but may still be approved (Art. 5 (2)), if the risk from exposure under realistic worst case use conditions is negligible (closed system or conditions prohibiting contact/release) evidence proves it is essential to prevent or to control a serious danger, or not approving would cause disproportionate negative impacts for society when compared with the risks from use, under specific consideration of alternative AS, techniques, risk-mitigation measures Candidates for substitution (Criteria Art. 10) Slide 29

30 AS Criteria for substitution - Art. 10 AS meets at least one of the exclusion criteria in Art. 5 (1) but is approved acc. Art. 5 (2); it is a a respiratory sensitiser; its ADI, AEL is significantly lower than those of the majority of approved AS for the same PT and use scenario; it meets two of the PBT criteria; there are reasons for concern linked to the nature of the critical effects and use patterns (e.g. for groundwater despite RMM); it contains a significant proportion of non-active isomers or impurities. flagged in the relevant Approval Regulation Specific tasks of ECHA: examination whether AS fulfills Art. 10, publication/consultation, substitutes, at the time of approval or renewal Slide 30

31 AS already established with 19 AS Commission may amend Annex I by delegated acts (Art. 28), if the AS does not give rise to concern by fulfilling the classification criteria explosive/highly flammable; organic peroxide; acutely toxic of category 1, 2 or 3; corrosive of category IA, IB or IC; respiratory sensitizer; skin sensitizer; germ cell mutagen, carcinogen, human reproductive toxicant of category 1 or 2 or with effects on or via lactation; specific target organ toxicant by single or repeated exposure; or toxic to aquatic life of acute category 1; or by fulfilling any of the substitution criteria; or they have neurotoxic or immunotoxic properties. Slide 31

32 AS transitional measures Art. 89, 90 Work Programme to proceed according to Art. 16 (2) COM delegated acts for any extension ECHA coordinates process of evaluation for dossiers submitted after 1 Sept 2012 AS/PT non-approval decision: MS may allow the making avilable of a BP on their national market up to 12 months no application for authorisation or mutual recognition in parallel or rejection: 180 d (market)/365 d (stocks) for dossiers submitted under the and evaluation not completed by 1 Sept 2013 (ECHA coordinates from 1 Jan 2014) evaluation to proceed according to on the basis of the information provided under the concerns arising from the application of the -> additional information allowed Slide 32

33 BP - Authorisation conditions I Art. 19 AS in the BP has to be listed in, except in case of a preliminary Auth of new AS (not restricted to the evaluating RefMS!), or in (see next slide for authorisation conditions); the specific provisions for the AS in Approval Act and AR are fulfilled, the BP is sufficiently effective has no unacceptable effects on the target organisms has no unacceptable effects itself/residues, on human or animal health, directly or indirectly (incl. vulnerable groups; drinking water, food, feed, air) has no unacceptable effect itself/residues, on the environment (fate and distribution; contamination of surface waters, groundwater and drinking water, air and soil; non-target organisms; biodiversity and ecosystem) Slide 33

34 BP - Authorisation conditions II Art. 19 continued: NEW i.a.: chemical identity/residues/te can be determined and where appropriate, MRLs for food and feed have been established if relevant: nanomaterials in the BP have to be assessed separately if relevant: The evaluation of whether a BP fulfils the criteria includes the use of treated articles treated with the BP or containing the BP cumulative and synergistic effects to be considered Biocidal products family authorisation (see later slide) Slide 34

35 - BP NOT for the general public Art. 19 (4) fulfilling the criteria according to Dir. 1999/45/EC as in BPD Art. 6 (2): toxic, very toxic, CMR cat. 1 or 2 fulfilling the criteria according to Reg. No 1272/2008 (CLP-Reg) for acute oral toxicity category 1 or 2 or 3; acute dermal toxicity category 1 or 2 or 3; acute inhalation toxicity (gases, dust/mist) category 1 or 2 or 3; acute inhalation toxicity (vapours) category 1 or 2; a category 1A or 1B carcinogen, mutagen, or toxic for reproduction; or fulfilling the criteria acc. to Annex XIII to Regulation No 1907/2006 (REACH Reg.) for PBT or vpvb it has endocrine-disrupting properties; or it has developmental neurotoxic or immunotoxic effects. BUT: disproportionate negative impacts for society make authorisation for general public possible, however only in MS with appropriate RMM! Slide 35

36 BP Comparative assessment I Art. 23 Comparative assessment as part of the evaluation of an application for authorization or for renewal of authorization of a BP containing an AS that is a candidate for substitution. Art. 23 (3), prohibition or restriction in case for the uses another authorized biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human and animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages; the chemical diversity of the active substances is adequate to minimize the occurrence of resistance. Art. 23 (7): Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to Art. 19 (3), that cancellation or amendment of the authorisation shall take effect four years after that decision; or if earlier - at expiry date. Slide 36

37 BP Comparative assessment II Art. 23 Art. 23 (6): Authorization shall be granted for a period not exceeding five years and renewed for a period not exceeding five years Art. 23 (4), excemption from Art. 23 (6): A BP containing an AS that is a candidate for substitution may be authorized for a period of up to four years without such an assessment where it is necessary to acquire experience first through using that product in practice If question relevant to two or more CA, the rca may refer the question to the Commission. COM Delegated Acts Slide 37

38 - Authorisations of BP with AS in Conditions Art. 25 all AS in the BP are in Annex I and satisfy any restriction specified in Annex I the BP does not contain any substance of concern the BP does not contain any nanomaterials the BP is sufficiently effective; and the handling of the biocidal product and its intended use do not require personal protective equipment. Procedure Art. 26f Application to ECHA including proposed eca 90 days for authorisation by eca; authorisation date in R4BP No need for mutual recognition but notification no later than 30 days before placing on the resp. MS market Slide 38

39 Obligatory data sharing Art. 62 If no significant differences to BP already authorised and no data protection, it is possible to refer to previous data Before performing a study with vertebrate animals, applicant have to ask ECHA (or can ask for other studies) ECHA shall provide name and contact details of data owner and submitter If study is still protected, applicant requests from the data owner the scientific-technical study data and the right to refer to the study make every effort to reach an agreement on the sharing of the data If no agreement after 30 d at the earliest -> info to ECHA, data owner within 60 days ECHA gives right to refer to the data (conditional: proof of effort, fractional payment to study owner) - appeal possible If data owner requests, national courts decide on the proportionate share of the cost ECHA guidance Slide 39

40 - Conditions for refusal of an authorisation by mutual recognition Art. 37 Art. 32 (2): all ConcMS shall authorise the BP under the same terms and conditions (as in RefMS), unless Art. 37 (1) - refusal is justified on grounds of: the protection of the environment; public policy or public security; the protection of health and life of humans, particularly of vulnerable groups, and of animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the target organisms not being present in harmful quantities. Slide 40

41 - Biocidal Products Family I Definition I - Art. 3 (1)(s) Is a group of biocidal products having similar uses, the active substances of which have 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. variations allowed a reduction in the percentage of one or more active substances, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. Slide 41

42 Art. 19 (6) - Biocidal Product Family II Authorisation of a BP family (no more individual authorisation within a frame formulation) if 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. Slide 42

43 - Biocidal Product Family III Art. 17 (6) An authorisation for a biocidal product may be granted for a single biocidal product or a biocidal product family The authorisation holder shall notify each CA that has granted a national authorisation for a BP family or in case of a Union authorisation ECHA and the Commission of each product within the BP family at least 30 days before placing it on the market, except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations. The notification shall indicate the exact composition, trade name and suffix to the authorisation number. Slide 43

44 - Biocidal Product Family authorisation Content of the SPC - Art. 22 in addition: suffixes to apply to individual biocidal products within the biocidal product family the quantitative composition with minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 % (COM Delegated Acts) Slide 44

45 - Treated Articles Definition Art. 3 (1) (a) A treated article that has a primary biocidal function shall be considered a BP (l) "treated article" means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more BP Conditions for placing on the market if not a BP - Art. 58 all AS in BP for treatment in the Union list or in Annex I with specific labelling (Art. 58 (3)) in case a biocidal claim is made, or if human contact/exposure of the environment is possible the AS approval conditions require it; i.a. including the names of all nanomaterials contained in the BP, followed by ("nano ) Consumer information rights Transitional measures Art. 94 Slide 45

46 - Obligation for notification of unexpected or adverse effects Art. 47 The holder of an authorisation shall without delay notify, in particular about new data/information on adverse effects of the AS or BP for humans, in particular vulnerable groups, or the environment; data indicating the potential of the AS for the development of resistance; new data or information indicating that the BP is not sufficiently effective. The CA or ECHA (who granted the authorisation) shall examine whether the authorisation needs to be amended or cancelled. The CA that granted the national authorisation shall immediately notify other MSs and COM on receipt of such information. Slide 46

47 - Cancellation or amendment of an authorisation Art. 48 Cancellation conditions for authorisation not satisfied, authorisation based on false or misleading information, or the authorisation holder has failed to comply with the obligations under the authorisation or the BPR. Amendments - COM Reg. on changes to authorised BP administrative changes: simplified notification procedure minor changes: reduced evaluation period major changes: evaluation period proportionate to the extent of the proposed change Slide 47

48 Detailed procedures for product authorisation Slide 48

49 Union authorisation Art. 41ff Art. 42 BP with similar conditions of use (guidance) across the Union except BP containing AS under Article 5 and except BP of PT 14, 15, 17, 20 and 21 from 1 September 2013: BP containing new AS and BP of PT 1, 3, 4, 5, 18 and 19 from 1 January 2017: BP of PT 2, 6 and 13 from 1 January 2020: all categories of BP Slide 49

50 Union authorisation procedure I Application (IUCLID) to ECHA with naming the eca ECHA notifies the eca that the application is available via R4BP ECHA informs the applicant of the fee, rejection if fee is not paid within 30 days Acceptance and information to eca and applicant eca Validation (30 days), i.e. no quality or adequacy check eca informs the applicant of the fee, rejection if fee is not paid within 30 days eca informs applicant, ECHA, other CAs with exact date of the validation Slide 50

51 Union authorisation procedure II Validation: incomplete, 90 days time limit for submission of additional information, validation (30 days) Validation: complete/rejection (part of paid fees reimbursed) eca evaluates dossier within 365* days (additional info needed: 180 days deadline in total) draft assessment report (PAR) and conclusions to applicant Applicant submits comments within 30 days eca take comment for finalisation of PAR into account eca sends PAR and conclusions to ECHA within 365* days ECHA sends to COM within 180 days an opinion on the authorisation of the BP Slide 51

52 Union authorisation procedure III ECHA opinion contains: a statement on whether the authorisation conditions (Art. 19 (1)) are fulfilled, a draft SPC, where relevant, details of terms or conditions which should be imposed, the final PAR. ECHA -> COM: Within 30 days SPC in all official languages COM implementing act for Union (non-)authorisation at a MS s justified request (on grounds of Art. 37 (1)) adjustment of conditions for the territory of that MS, incl. non-application of the Union authorisation. Renewal: application at least 550 days before the expiry date Slide 52

53 - National authorisation procedure I Art. 29f Application submitted to rca rca informs applicant of the fee, rejection if fee is not paid within 30 days Acceptance, date Validation within 30 days (no quality or adequacy check) Incomplete, 90 days time limit for submission of additional information Validation (30 days) Validation: complete or rejection, date Slide 53

54 - National authorisation procedure II r/eca: 365* days for evaluation (additional info: 180 days deadline) Within 365 days draft PAR sent to applicant (e-copy) Applicant submit comments within 30 days r/eca take comment for finalisation of AR into account r/eca enter in R4BP SPC final PAR any terms or conditions imposed on the making available on the market E-copy to applicant Renewal: application at least 550 days before expiry date Slide 54

55 - Mutual recognition procedures - Art. 32ff in sequence- Art. 33 in parallel Art. 34 Slide 55

56 - Mutual recognition procedures I Mutual recognition in sequence For BP authorisations already granted in another MS ConcMS shall agree on SPC in R4BP within days ConcMS authorise within further 30 days Mutual recognition in parallel Application submitted to RefMS and ConcMS at the same time Commenting round on draft PAR and SPC (ConcMS and applicant) within 365 days ConcMS shall agree on SPC in R4BP within 90 days RefMS and ConcMS authorise within further 30 days Slide 56

57 Parallel trade permit Art. 53 Granted by the CA of the "MS of introduction on application within 60 days if the BP has been authorised in another MS ("MS of origin") and demonstrated to be identical to a BP already authorised in the MS of introduction ("the reference product") by data submitted by the applicant or/and By data supplied by the MS of origin to the MS of introduction on request Conditions to be fulfilled - Art. 53 (3) Application information requirements - Art. 53 (4) same conditions as the authorisation of the reference product Duration of validity like ref. product in the MS of introduction may be withdrawn if the authorisation of the introduced biocidal product is withdrawn in the MS of origin because of safety or efficacy reasons. Slide 57

58 Derogations Art. 55 Temporary permit by a CA for a limited and controlled use under the supervision of the CA for max. 180 days (entspr. Gefahr im Verzug ) extension for max. 550 days (COM implementing act) Preliminary authorisation of a BP containing a new AS for max. three years extension for max. one year COM implementing act may allow a MS to authorise a BP containing a non-approved AS if the AS is essential for the protection of cultural heritage, if no appropriate alternatives Research and development Art. 56 Slide 58

59 Authorisations transitional measures Art. 91ff applications submitted under the and evaluation not completed by 1 Sept 2013 (Art. 91) evaluation to proceed according to If one or more of the criteria listed under Art. 5(1) is met: authorisation in accordance with Art. 19 ; If one or more of the criteria listed under Art. 10 is met: authorisation in accordance with Article 23 concerns arising from the application of the -> additional information allowed BP authorised or registered in accordance with the before 1 September 2013 (Art. 92) Granting conditions remain valid until the expiry date applies from 1 September 2013 BP not covered by the scope of the BPD but by the scope of the and available on the market on 1 September 2013 (Art. 93) applications for authorisation shall be submitted at the latest by 1 September 2017 may continue on the market until the date of the decision granting the authorisation Slide 59

60 Refill I, selected new features MS shall advice applicants, esp. SME (e.g. by helpdesk) Treated articles (BP and not BP) Special protection of vulnerable groups Charges to ECHA and MS CAs, possibility of reimbursement in case of rejection for incompleteness or for failing deadlines Art. 95 active substance inventory (except substances in BPR Annex I) Parallel Trade permit Changed rules for data sharing Annex IV General rules for the adaptation of the data requirements Slide 60

61 Refill II, selected new features R4BP as data bank Possibility for official or scientific bodies to apply for authorisation by mutual recognition mutual recognition application to contain draft SPC SPC published by ECHA (Art. 67 (2)) validation instead of completeness check AS evaluation incl. cumulative effects (only biocidal uses, incl. consideration of other AS) Technical Equivalence check by ECHA report by COM to the EU Parliament & Council on measures by BPR supporting sustainable use of BP, within three years Slide 61

62 Competent Authority for Biocidal Products in AT Address AL Dr. Edmund Plattner Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft (Federal Ministry for Agriculture, Forrestry, Environment and Water Management) Abteilung V/3 Stubenbastei Wien edmund.plattner@lebensministerium.at BP applications additionally Cc to bp.zulassungen@umweltbundesamt.at Slide 62

63 Contact & Information Elisabeth Fassold, MTox, Dr. M: +43-(0) T: +43-(0) /5912 F: +43-(0) /3211 Umweltbundesamt GmbH (Austrian Environment Agency) Spittelauer Lände Wien Österreich/Austria SDSs, questions and technical consultation requests to: biozide@umweltbundesamt.at Slide 63