Guidance on active substance suppliers

Transcription

1 G U I D A N C E Guidance n active substance suppliers GUIDANCE ON REGULATION (EU) N 528/2012 CONCERNING THE MAKING AVAILABLE ON THE MARKET AND USE OF BIOCIDAL PRODUCTS (BPR) Versin 1.0 July 2013

2 2 Guidance n active substance suppliers Versin 1.0 July 2013 LEGAL NOTE This dcument cntains guidance n Regulatin (EU) N 528/2012 f the Eurpean Parliament and f the Cuncil f 22 May 2012 cncerning the making available n the market and use f bicidal prducts (Bicidal Prducts Regulatin, the BPR). This dcument describes the BPR bligatins and hw t fulfil them. Hwever, users are reminded that the text f the BPR is the nly authentic legal reference and that the infrmatin in this dcument des nt cnstitute legal advice. The Eurpean Chemicals Agency des nt accept any liability with regard t the cntents f this dcument. Versin Changes Date 1.0 First editin July 2013 Guidance n active substance suppliers Reference: ECHA-13-G-07-EN ISBN: Publ. date: July 2013 Language: EN Eurpean Chemicals Agency, 2013 Cver page Eurpean Chemicals Agency Reprductin is authrised prvided the surce is fully acknwledged in the frm Surce: Eurpean Chemicals Agency, and prvided written ntificatin is given t the ECHA Cmmunicatin Unit (publicatins@echa.eurpa.eu). If yu have questins r cmments in relatin t this dcument please send them (qute the reference and issue date) using the infrmatin request frm. The infrmatin request frm can be accessed via the Cntact ECHA page at: Eurpean Chemicals Agency Mailing address: P.O. Bx 400, FI Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland

3 Guidance n active substance suppliers Versin 1.0 July Table f Cntents 1. INTRODUCTION INTENTION AND BASIC PROVISIONS OF ARTICLE Intentin f Article Prcess f Article 95 and regulatry cnsequences Prcess Regulatry cnsequences SUBMISSIONS UNDER ARTICLE Wh shuld submit the infrmatin requested under Article 95? Which infrmatin shuld be submitted? Data sharing COMPLIANCE CHECK OF SUBMISSIONS LIST PUBLISHED ACCORDING TO ARTICLE 95(2) Wh will be placed n the list Maintenance f the list REFERENCES ANNEX I TEXT OF ARTICLE 95 OF THE BPR... 14

4 4 Guidance n active substance suppliers Versin 1.0 July 2013 List f abbreviatins Standard term / Abbreviatin BPD BPR LA R4BP Explanatin Bicidal Prducts Directive. Directive 98/8/EC f the Eurpean Parliament and f the Cuncil n the placing n the market f bicidal prducts Bicidal Prducts Regulatin. Regulatin (EU) N 528/2012 f the Eurpean Parliament and f the Cuncil cncerning the making available n the market and use f bicidal prducts Letter f access Register fr Bicidal Prducts

5 Guidance n active substance suppliers Versin 1.0 July Intrductin Article 95 f the f the Bicidal Prducts Regulatin (EU) N 528/2012 (BPR) is titled Transitinal measures cncerning access t the active substance dssier. The full text f Article 95 is presented in Annex I f this Guidance. The bjective f thse prvisins is set ut in Recital 8 f the BPR which states that T ensure the equal treatment f persns placing active substances n the market, they shuld be required t hld a dssier r have a letter f access t a dssier, r t relevant data in a dssier, fr each f the active substances they manufacture r imprt fr use in bicidal prducts.. This Guidance explains which entities have a direct bligatin t make a submissin under Article 95, thse which will be cnsidered t have made such a submissin and prvides guidance n the regulatry cnsequences. A submissin manual n hw t submit via the Register fr Bicidal Prducts (R4BP) will be published separately by ECHA. It must be nted that the Cmmissin has prepared a prpsal n an amendment t the BPR which cntains amng thers several amendments t Article 95. This prpsal, dated 16 May 2013, can be fund at: ECHA will revise this Guidance dcument, where necessary, if this prpsal is adpted.

6 6 Guidance n active substance suppliers Versin 1.0 July Intentin and basic prvisins f Article Intentin f Article 95 The intentin f Article 95 is laid dwn in recital (8) f the BPR: T ensure the equal treatment f persns placing active substances n the market, they shuld be required t hld a dssier r have a letter f access t a dssier, r t relevant data in a dssier, fr each f the active substances they manufacture r imprt fr use in bicidal prducts. Bicidal prducts cntaining active substances fr which the relevant persn des nt cmply with that bligatin shuld n lnger be made available n the market. In such cases there shuld be apprpriate phase-ut perids fr dispsal and use f existing stcks f bicidal prducts. The bjective f ensuring equal treatment f persns placing active substances n the market is aimed mainly at alternative suppliers. Alternative suppliers are manufacturers r imprters f an active substance, which d nt supprt the Unin apprval f an active substance yet benefit frm the regulatry regime. In particular they include thse wh are nt participants in the Review Prgramme 1 under the Bicidal Prducts Directive 98/8/EC (BPD) yet place existing active substances 2 n the market (either n their wn r in a bicidal prduct) befre apprval, but they als include thse wh are newcmers after the active substance is apprved. 3 In ther wrds, the aim is t ensure that all players cntribute t the csts f the active substance apprval prcess during the perid when they place the active substance n the market. The equal treatment bjective f Article 95 is implemented thrugh the publicatin by ECHA f the list f active substances suppliers which either made the submissin under Article 95(1) r wh are cnsidered t have made such a submissin. The latter entails the participants in the Review Prgramme but als entities supprting new active substances (applicatins under Article 11 f the BPD r Article 7 f the BPR). Suppliers will remain n the list published by ECHA pst apprval f the relevant active substance in rder fr a cmprehensive list f suppliers entitled t place active substances n the market t be established. Only bicidal prducts cntaining an active substance supplied frm an entity n the list may be made available n the market after 1 September Prcess f Article 95 and regulatry cnsequences Prcess In summary the prcess under Article 95 is as fllws: - Alternative suppliers have t submit infrmatin t ECHA as specified in Article 95(1): a dssier, a letter f access (LA) r a reference t a dssier fr which all 1 In the BPR the Review Prgramme is referred t as the wrk prgramme established under the first subparagraph f Article 89(1). 2 Recital 7 f the BPR defines existing and new active substances: A distinctin shuld be drawn between existing active substances which were n the market in bicidal prducts n the transpsitin date set in Directive 98/8EC and new active substances which were nt yet n the market in bicidal prducts at that date. 3 After an active substance is apprved any entity wishing t place a bicidal prduct cntaining that active substance n the market requires an authrisatin fr the bicidal prduct. The applicatin prcess invlves submitting a dssier n the active substance, r a LA theret btained frm the entity which supprted the apprval f the active substance. After the bicidal prduct authrisatin is btained, the entity is free t change its surce f supply t anther cmpany prvided this cmpany is included n the list f relevant persns published by ECHA under Article 95(2) and therefre participated in the csts f the assessment f the active substance.

7 Guidance n active substance suppliers Versin 1.0 July data prtectin perids have expired. The submissin is subject t a fee as specified in Annex III f Cmmissin Implementing Regulatin (EU) N 564/2013 n the fees and charges payable t the Eurpean Chemicals Agency pursuant t Regulatin (EU) N 528/2012 (Implementing Regulatin (EU) N 564/2013). - Supprters f new active substances and participants in the Review Prgramme will be cnsidered as having made a submissin under Article 95(1) and d nt need t take any measures. - ECHA carries ut a cmpliance check n the infrmatin submitted by the alternative suppliers. - As specified in Article 95(2) ECHA publishes a list cntaining the alternative suppliers wh submitted the infrmatin under Article 95(1) and passed the cmpliance check. The list will als cntain the participants in the Review Prgramme and supprters f new active substances pst cmpleteness check Regulatry cnsequences As specified in Article 95(3) as f 1 September 2015, bicidal prducts shuld nt be made available n the market if the manufacturer r imprter f the active substance(s) in the prduct, r the imprter f the bicidal prduct is nt included n this list. As a cnsequence a frmulatr wh is neither a manufacturer nr imprter f the active substance(s) used in its frmulatins must ensure that its supplier(s) f the active substance(s) are n the list. It is imprtant t nte that the requirement t be n the list applies als after an active substance prduct-type cmbinatin is apprved. This means that newcmers (first time manufacturers r imprters wanting t enter the EU market) als need t be listed. The bligatins fr alternative suppliers apply frm 1 September Since the regulatry cnsequences apply frm 1 September 2015 nwards it is recmmended that alternative suppliers submit well in time and preferably as sn as pssible after 1 September It has t be nted that Article 95 als states that: - The relevant persn t whm a LA t the dssier n the active substance has been issued shall be entitled t allw applicants fr the authrisatin f a bicidal prduct cntaining that active substance t make reference t that LA in applicatins fr prduct authrisatin as described in Article 20(1); - By way f dergatin frm Article 60 f the BPR, all data prtectin perids fr active substance prduct-type cmbinatins listed in Annex II t Regulatin (EC) N 1451/2007, but nt yet apprved under the BPR shall end n 31 December It shuld als be nted that althugh nt explicitly mentined in Article 95, the new studies submitted by the alternative suppliers will ptentially be used by the authrities fr risk assessment purpses.

8 8 Guidance n active substance suppliers Versin 1.0 July Submissins under Article Wh shuld submit the infrmatin requested under Article 95? The prcedure under Article 95 cncerns manufacturers r imprters (r assciatins theref) f an active substance n its wn r in a bicidal prduct wishing t place these n the EU market after 1 September Thse affected can be distinguished int tw grups: - Thse wh have t make an applicatin and submit the infrmatin requested under Article 95: alternative suppliers f active substances in the Review Prgramme 4 and f new actives pst apprval; the imprter f the bicidal prduct cntaining the active substance(s) if the relevant persn is nt a natural r legal persn established in the Eurpean Unin. - Thse wh will be placed autmatically n the list and will thus nt have t make an applicatin and submit the infrmatin requested under Article 95: participants in the Review Prgramme; supprters f new active substances (thse wh submitted a dssier under Article 11 f the BPD r under Article 7 f the BPR): their applicatin will be cnsidered as equivalent t the submissin required under Article 95 and they will be added t the list after passing the cmpleteness check. The fllwing situatins d nt fall within the scpe f Article 95 and therefre n submissin is required: - entities manufacturing r imprting active substances listed in Annex I f the BPR in categries 1 t 5 and 7 r bicidal prducts cntaining nly such active substances n the market; - entities wh submitted an applicatin under Article 93. This relates t active substances in bicidal prducts cvered by the BPR but nt by the BPD and available n the EU market n 1 September 2013 and which are nt included in the Review Prgramme. In particular, this relates t in-situ generated active substances. Nte that in the case f re-imprts f an active substance manufactured in the EU, the reimprter shuld ensure that his active substance(s) supplier (the EU manufacturer) is n the list published under Article 95(2). 3.2 Which infrmatin shuld be submitted? In accrdance with Article 95(1), the infrmatin t be prvided cnsists f: (a) a dssier cmplying with the requirements f Annex II, r where apprpriate, with 4 It is nted that this includes alternative suppliers fr the active substances listed in Categry 6 f Annex I f the BPR: carbn dixide, nitrgen and (Z,E)-Tetradec-9,12-dienyl acetate.

9 Guidance n active substance suppliers Versin 1.0 July Annex IIA f Directive 98/8/EC; r (b) a letter f access t a dssier as referred t under pint (a); r (c) a reference t a dssier as referred t under pint (a) and fr which all data prtectin perids have expired. Submissins can cnsist f bth a LA and data fr the endpints nt cvered by the LA 5. Sme remarks n these submissins: - Article 95 des nt require the prir establishment f technical equivalence via an applicatin t ECHA under Article 54. Hwever regardless f the submissin type (full dssier, LA r a cmbinatin f bth) infrmatin regarding the identity f the active substance as defined in Annex II f the BPR r Annex IIA f the BPD needs t be prvided. - fr a dssier submitted cmplying with the infrmatin requirements in Annex II f the BPR r Annex IIA f the BPD it is required t submit the fllwing (in line with Annex III f Regulatin (EC) 1451/2007 which specifies the requirements fr the cmplete dssier and summary dssier fr submissins under the Review Prgramme): Dcument II A summarising the intrinsic prperties f the active substance, Dcument III A ((rbust) study summaries), Dcument IV (riginal test reprts) level and an IUCLID file (see Part I f the Technical Nte fr Guidance (TNsG) n Dssier Preparatin and Study Evaluatin published under the BPD 6 fr an explanatin f the dssier structure including Dcument II, III and IV). An applicant may prpse t adapt the data as explained in Article 6(2) f the BPR. If data are waived a justificatin will have t be prvided. It is nt allwed t submit a test prpsal as therwise the dssier des nt satisfy the data requirements and is therefre incmplete; a reference list f the studies submitted; Listing f Endpints (LOEP) (see Part I f the TNsG n Dssier Preparatin and Study Evaluatin published under the BPD 6 fr an explanatin f the LOEP). - where relevant the decisin frm ECHA n the permissin t refer t requested data in line with Article 63 must be submitted (see als belw sectin 3.3); - a LA shuld cntain at least (Article 61) : the name and cntact details f the data wner and the beneficiary; the name f the active substance r bicidal prduct fr which access t the data is authrised; the date n which the letter f access takes effect; a list f the submitted data t which the letter f access grants citatin 5 It must be nted that future develpments in the Review Prgramme may be cnsidered, as the evaluatin by the Rapprteur Member State is n-ging fr the cncerned active substance prduct-type cmbinatin: additinal data may be requested during this prcess. 6 This TNsG is available frm the ECHA web-site at:

10 10 Guidance n active substance suppliers Versin 1.0 July 2013 rights. - fr the endpints nt cvered by the LA, the infrmatin stated abve (Dcument II, III and IV (riginal test reprts), an IUCLID file, reference list and LOEP) needs t be submitted. As stated abve, the submissin under Article 95(1) is subject t a fee t be paid t ECHA as set ut in Annex III f Implementing Regulatin (EU) N 564/2013. The fee depends n the cntent f the submissin: i) Fee per submissin f a letter f access t a dssier already fund cmplete by the Agency r an evaluating Cmpetent Authrity: EUR 2,000 ii) Fee per submissin f a letter f access t part f a dssier already fund t be cmplete by ECHA r an Evaluating CA, tgether with cmplementary data: EUR 20,000; iii) Fee per submissin f a new dssier: EUR 40,000. Alternative suppliers will have t submit the required infrmatin thrugh the Register fr Bicidal Prducts. This Guidance des nt cntain detailed guidance n hw t submit applicatins thrugh the Register. This will be made available separately by ECHA via the publicatin f a submissin manual. This will cntain a template fr a LA which may be used by alternative suppliers. 3.3 Data sharing The data sharing prvisins f Chapter XIV n data prtectin and data-sharing f the BPR apply in the cntext f submissins under Article 95(1). Furthermre, in the cntext f Article 95(1), the prvisins f Article 63(3) apply nt nly t tests invlving vertebrate animals but als t tests nt invlving vertebrate animals (as described in Sectins 8 and 9 f Annex II f the BPR). The extended applicatin f Article 63(3), by virtue f Article 95(1), is nly in relatin t active substances in the Review Prgramme and des nt apply t new active substances. If the alternative supplier and the data wner f the study cannt reach an agreement n sharing data, the alternative supplier shuld infrm ECHA. ECHA has n rle in the negtiatins and cannt be a party r take ver this respnsibility. The task f ECHA in the cntext f the data sharing dispute claim is t assess whether the parties have made every effrt t reach an agreement n the sharing f data under fair, transparent and nndiscriminatry cnditins. ECHA will perfrm an assessment based n the dcumentary evidence submitted by bth parties invlved in the negtiatins. Any decisin taken by ECHA t grant permissin t the alternative supplier will nly be taken after the latter has demnstrated that every effrt has been made t reach an agreement with the data wner. Furthermre, the alternative supplier must shw that it has paid a share f the csts incurred by the data wner. In case f a decisin in favur f the data wner, ECHA recmmends the parties t cntinue negtiating even thugh a dispute claim was submitted. As the data sharing prvisins under the BPR are similar t thse under the REACH Regulatin, reference is made t the Guidance n data sharing under REACH available n the ECHA web-site (ECHA, 2012). 4. Cmpliance check f submissins After the submissin, ECHA will check if the infrmatin submitted is cmplete and cmplies with the requirements f Article 95(1): - is the infrmatin prvided (directly and/r indirectly thrugh a LA) fr all the

11 Guidance n active substance suppliers Versin 1.0 July endpints required, including justificatins fr the adaptatin f infrmatin requirements, cmplete with respect t the requirements f Annex II f the BPR r, where apprpriate with Annex IIA f the BPD? - if a dssier is submitted, ECHA will check that the identity f the active substance supprts the submissin; - if a LA is submitted, ECHA will check that the identity f the active substance makes the LA relevant t supprt the submissin; - fr the studies submitted ECHA will check whether the infrmatin prvided fr the endpints required, including waiving statements, is adequate and f sufficient quality; - if a LA is submitted, ECHA will check if the LA cmplies with Article 61 f the BPR; - if the submissin cnsists f a reference t a dssier fr which it is claimed that all data prtectin perids have expired ECHA will check this claim. A psitive utcme f the cmpliance check is a cnditin fr being placed n the list. ECHA will infrm the applicant if the submissin is nn-cmpliant stating als the reasn(s) fr the nn-cmpliance. It is recmmended that alternative suppliers submit as sn as pssible after 1 September 2013 t maximise the time fr the cmpliance check. In case f a late submissin ECHA cannt guarantee that the cmpliance check is finished befre 1 September 2015, enabling ECHA t decide befre that deadline if the alternative supplier will be placed n the list.

12 12 Guidance n active substance suppliers Versin 1.0 July List published accrding t Article 95(2) 5.1 Wh will be placed n the list ECHA will publish via its web-site a list f persns cntaining the names f: - the alternative suppliers wh submitted the infrmatin required under Article 95(1) and wh passed the cmpliance check; - the alternative suppliers fr whm a decisin has been taken by ECHA t give the permissin t refer t the requested tests r studies in accrdance with Article 63(3). It shuld be nted (as stated abve in Sectin 4) that the alternative supplier will nly be added t the list by ECHA if the remaining data n the active substance are prvided, either thrugh a LA r the generatin f data, t fulfil the requirements f submitting a cmplete dssier; - the participants in the Review Prgramme; - applicants wh submitted a cmplete dssier fr a new active substances under Article 11 f the BPD (new active substances) r a cmplete dssier under Article 7 f the BPR; - alternative suppliers 7 wh submitted their wn dssier fr an active substance included n Annex I under the BPD t a Member State fr prduct authrisatin under the cnditin that the dssier is cmplete. Nte that the situatin f frmulatrs is addressed in the Cmmissin s prpsals t amend the BPR (see sectin 1), therefre this area may be subject t change. 5.2 Maintenance f the list As f 1 September 2013 ECHA will publish the list cntaining the names f the participants n the web-site. Supprters f new actives applicants under Article 11 f the BPD and applicants under Article 7 f the BPR will be included n the list pst cmpleteness check. The alternative suppliers wh submitted an applicatin under Article 95(1) and passed the cmpliance check will then gradually be added t the list. The active substance suppliers will remain n the list pst apprval f the relevant active substance. Newcmers after 1 September 2013 which are either alternative suppliers supplying existing active substances pre apprval r pst apprval r supplying apprved new active substances, will als need t make an Article 95(1) submissin and be included n the list. The pst apprval cntinuatin and expansin f the list is t ensure that all entities placing the active substance n the market have access t the relevant data in rder t ensure equal treatment (fr example in case f pst apprval change f supplier). 7 These are als called third party dssiers.

13 Guidance n active substance suppliers Versin 1.0 July References ECHA 2012, Guidance n data sharing.

14 14 Guidance n active substance suppliers Versin 1.0 July 2013 Annex I Text f Article 95 f the BPR Article 95: Transitinal measures cncerning access t the active substance dssier 1. As f 1 September 2013, any persn wishing t place active substance(s) n the Unin market n its wn r in bicidal prducts (the "relevant persn") shall, fr every active substance that they manufacture r imprt fr use in bicidal prducts, submit t the Agency: (a) a dssier cmplying with the requirements f Annex II, r where apprpriate, with Annex IIA f Directive 98/8/EC; r (b) a letter f access t a dssier as referred t under pint (a); r (c) a reference t a dssier as referred t under pint (a) and fr which all data prtectin perids have expired. If the relevant persn is nt a natural r legal persn established within the Unin, the imprter f the bicidal prduct cntaining such active substance(s) shall submit the infrmatin required under the first subparagraph. Fr the purpses f this paragraph and fr existing active substances listed in Annex II t Regulatin (EC) N 1451/2007, Article 63(3) f this Regulatin shall apply t all txiclgical and ectxiclgical studies including any txiclgical and ectxiclgical studies nt invlving tests n vertebrate animals. The relevant persn t whm a letter f access t the dssier n the active substance has been issued shall be entitled t allw applicants fr the authrisatin f a bicidal prduct cntaining that active substance t make reference t that letter f access fr the purpses f Article 20(1). By way f dergatin frm Article 60 f this Regulatin, all data prtectin perids fr substance/prduct-type cmbinatins listed in Annex II t Regulatin (EC) N 1451/2007, but nt yet apprved under this Regulatin shall end n 31 December The Agency shall make publicly available the list f persns that have made a submissin in accrdance with paragraph 1 r fr whm it has taken a decisin in accrdance with Article 63(3). The list shall als cntain the names f persns wh are participants in the wrk prgramme established under the first subparagraph f Article 89(1) r have taken ver the rle f the participant. 3. Withut prejudice t Article 93, as f 1 September 2015, a bicidal prduct shall nt be made available n the market if the manufacturer r imprter f the active substance(s) cntained in the prduct, r where relevant, the imprter f the bicidal prduct, is nt included in the list referred t in paragraph 2. Withut prejudice t Article 52 and 89 dispsal and use f existing stcks f bicidal prducts cntaining an active substance, fr which n relevant persn is included in the list referred t in paragraph 2, may cntinue until 1 September This Article shall nt apply t active substances listed in Annex I in categries 1 t 5 and 7 r t bicidal prducts cntaining nly such active substances.

15 EUROPEAN CHEMICALS AGENCY ANNANKATU 18, P.O. BOX 400, FI HELSINKI, FINLAND ECHA.EUROPA.EU