New EU Bicidal Regulatin: Treated Articles The Bicidal Prduct Regulatin EU 528/2012 ( BPR ) cmes int effect n 1 September 2013 1. It replaces the Bicidal Directive 98/8/EC. The BPR will be binding in its entirety and directly applicable in all Member States f the Eurpean Unin. The BPR cncerns cmpanies making bicidal prducts available n the EU market and the placing n the market f treated articles. It als deals with the use f the active substances cntained in bicidal prducts t prtect humans, animals, materials r articles against harmful rganisms, such as pests r bacteria, writes Dr Rsanna Cper. The idea behind the BPR is t ensure that bicidal prducts and treated articles are authrised. Bicidal prducts shuld neither be made available n the market nr used unless authrised in accrdance with this Regulatin. Treated articles shuld nt be placed n the market unless all active substances cntained in the bicidal prducts with which they were treated r which they incrprate are apprved in accrdance with this Regulatin.. The purpse f this Regulatin is t imprve the free mvement f bicidal prducts within the Unin while ensuring a high level f prtectin f bth human and animal health and the envirnment Befre any bicidal prduct can be placed n the market in the EU, it must have an authrisatin, and the active substances cntained in that bicidal prduct must be previusly apprved. Please nte there are exceptins: Active substances under the review prgramme; Bicidal prducts cntaining these active substances can be placed n the market while awaiting the final decisin n the apprval; Prvisinal prduct authrisatins fr new active substances that are still under assessment are als allwed n the market. 1 A regulatin ensures that legal requirements are implemented at the same time and in a harmnised manner thrughut the Eurpean Unin 1 P a g e
In the BPR it states that: Rules shuld be laid dwn fr the apprval f active substances and the making available n the market and use f bicidal prducts, including rules n the mutual recgnitin f authrisatins and n parallel trade. Purpse f the BPR This BPR lays dwn rules fr: The establishment at Unin level f a list f active substances which may be used in bicidal prducts; The authrisatin f bicidal prducts; The mutual recgnitin f authrisatins within the Unin; The making available n the market and the use f bicidal prducts within ne r mre Member States r the Unin; The placing n the market f treated articles. What is a Bicidal Prduct? Under the BPR, a bicidal prduct means: any substance r mixture, in the frm in which it is supplied t the user, cnsisting f, cntaining r generating ne r mre active substances, with the intentin f destrying, deterring, rendering harmless, preventing the actin f, r therwise exerting a cntrlling effect n, any harmful rganism by any means ther than mere physical r mechanical actin, any substance r mixture, generated frm substances r mixtures which d nt themselves fall under the first indent, t be used with the intentin f destrying, deterring, rendering harmless, preventing the actin f, r therwise exerting a cntrlling effect n, any harmful rganism by any means ther than mere physical r mechanical actin Under the BPR: 2 P a g e
An active substance means a substance r a micr-rganism that has an actin n r against harmful rganisms. Making available n the market means any supply f a bicidal prduct r f a treated article fr distributin r use in the curse f a cmmercial activity, whether in return fr payment r free f charge. Placing n the market means the first making available n the market f a bicidal prduct r f a treated article. Use means all peratins carried ut with a bicidal prduct, including strage, handling, mixing and applicatin, except any such peratin carried ut with a view t exprting the bicidal prduct r the treated article utside the Unin. Authrisatin means natinal authrisatin, Unin authrisatin r authrisatin in accrdance with Article 26. Letter f access means an riginal dcument, signed by the data wner r its representative, which states that the data may be used fr the benefit f a third party by cmpetent authrities, the Agency, r the Cmmissin fr the purpses f the BPR. It is imprtant t nte that any treated article that has a primary bicidal functin will be deemed a bicidal prduct. What is a Treated Article? Under Article 3 the BPR, a treated article is defined as: A treated article means any substance, mixture r article which has been treated with, r intentinally incrprates, ne r mre bicidal prducts The BPR intrduces mandatry data sharing bligatins whilst encuraging the use f alternative testing methds. 3 P a g e
The table belw gives the HSE s current view f what a treated article and a bicidal prduct are (this is subject t change nce further guidance is published at the Eurpean level) 2. Type f article Article treated with a bicide (e.g. a wden bench painted with wd preservative) with the sle intentin f cntrlling rganisms harmful t the treated article/material itself Article is treated with a bicide and the primary functin f the article is nt as a bicide (e.g. antibacterial sck) Article is treated with a bicide and the primary functin f the article is as a bicide (e.g. antibacterial wipe) Treated Article r Bicidal Prduct Treated Article must cmply requirements in Article 58 Treated Article must cmply requirements in Article 58 Bicidal Prduct which requires authrisatin The BPR requires manufacturers and imprters f treated articles t label their prducts when: A claim is made that the treated article has bicidal prperties; The cnditins f the apprval f the active substance use t treat the article require specific labelling prvisins t prtect public health r the envirnment. Under REACH, cnsumers may request frm the supplier f a treated article infrmatin n the bicidal treatment f the treated article. This infrmatin must be prvided with 45 days and free f charge. Bicidal Prducts already Authrised under the UK BPR Any authrisatin/registratin granted under the UK BPR will be valid and all existing cnditins and restrictins will cntinue t apply until the expiry f the authrisatin r it is revked r cancelled (Article 92). 2 Acknwledgement table reprduced frm HSE website 4 P a g e
Frm 1 September 2013, the requirements f the BPR will als apply t such authrisatin/registratin. Bicidal Prduct Families An authrisatin may be granted fr a bicidal prduct r a bicidal prduct family. An authrisatin will be granted fr a maximum perid f 10 years. In accrdance with Article 3, a bicidal prduct family is defined as: a grup f bicidal prducts having similar uses, the active substances f which have the same specificatins, and presenting specified variatins in their cmpsitin which d nt adversely affect the level f risk r significantly reduce the efficacy f the prducts Under the BPR, all prducts within the bicidal prduct family will be cvered by ne authrisatin. Key issues With regard t the Bicidal Directive 98/8/EC, there have been less than 60 substance reviews cmpleted, and arund 12 r s prducts authrised. The pint is that a number f active substances have been withdrawn due t the high csts f supprting these prducts thrugh the authrisatin prcess. The aim f the BPR is t simplify and streamline existing EU requirements whilst maintaining a high level f prtectin t health and the envirnment. Fr cmpanies currently marketing bicidal prducts r prducing active substances, there is n need t take any actin right nw, particularly, if the applicatin fr an active substance and/r bicidal prduct is under review in accrdance with the Bicidal Directive 98/8/EC and current UK regulatins. Gaining apprval under the BPR fllws the same tw-step prcedure as under the Bicidal Directive 98/8/EC: Fr the apprval f active substances at EU level; and 5 P a g e
The authrisatin f bicidal prducts in Member States. Under the BPR, the current review prgramme f active substances will cntinue. There is a clear prcedure fr evaluatin and apprval f bth bicidal prducts and active substances. What are the changes under the BPR? The changes brught abut by the BPR will affect businesses selling bicidal prducts and/r prducing active substances: Cmpanies will have the ptin t apply fr authrisatin f a bicidal prduct acrss the whle f the EU by applying t the Eurpean Chemicals Agency (ECHA). The BPR prvides fr ECHA t deal with applicatins fr the apprval f active substance. The BPR makes allwances fr cmpanies t surce active substances frm ther cmpanies ther than the suppliers f the active substances listed in supprt f applicatins. This means that when cmpanies are making bicidal prducts available n the EU market the suppliers f the active substances must have access t the data that supprts the applicatins Imprve the mutual recgnitin prcess by the intrductin f binding deadlines and a strnger system fr mutual recgnitin dispute settlement; A database f suppliers will be maintained by ECHA. If yu are imprting an article int the EU that is treated with a bicide, yu will have t ensure that the active substance f the bicide is apprved under the BPR. Any bicidal claims fr the treated article, shuld carry a label with infrmatin abut the bicide; The BPR has a tw-step apprach fr evaluatin; 6 P a g e
Sme bicidal prducts can be authrised at the Unin level granting direct access t the entire Unin market. Obligatry data sharing is intended t reduce the number f animal tests in relatin t vertebrate animal studies; Any persn placing bicidal prducts n the market will be required t hld the data n active substances. In mst cases there are transitinal arrangements befre these prvisins apply fully. Simplified Authrisatin Prcedure fr Bicidal Prducts There is a distinctin between the apprval f active substances and bicidal prducts. The apprval f active substances takes place at Unin level and the authrisatin f bicidal prducts at Member State level, the HSE in this case. The list f active substances can be fund in Annex I f the BPR. The prcess is extended t ther Member States by mutual recgnitin. The BPR allws fr authrisatin at Unin level. Article 27 f the BPR prvides that nce a prduct is authrised in at least ne Member State, the prduct can be made available n the market in all Member States withut the need fr mutual recgnitin, prvided certain cnditins are met. The applicatin fr authrisatin f certain bicidal prducts may be eligible under the simplified authrisatin prcedure, prvided the cnditins are met: All the active substances cntained in the bicidal prduct appear in Annex I and satisfy any restrictin specified in that Annex; The bicidal prduct des nt cntain any substance f cncern; The bicidal prduct des nt cntain any nanmaterials; The bicidal prduct is sufficiently effective; and 7 P a g e
The handling f the bicidal prduct and its intended use d nt require persnal prtective equipment. If all f the cnditins abve are met by the applicant, the applicant will be required t submit an applicatin t ECHA in accrdance with its prcedure. If the applicatin r prspective authrisatin hlder fails t pay the fees t the cmpetent authrity in 30 days, the applicatin will be rejected. Applicatins fr authrisatin shall be made by, r n behalf f, the prspective authrisatin hlder.. It is wrth nting that: A bicidal prduct authrised in accrdance with Article 26 may be made available n the market in all Member States withut the need fr mutual recgnitin. Hwever, the authrisatin hlder shall ntify each Member State n later than 30 days befre placing the bicidal prduct n the market within the territry f that Member.. Member States can restrict the marketing f bicidal prducts in the EU: Where a Member State has valid reasns t cnsider that a bicidal prduct authrised in accrdance with Article 26 des nt meet the criteria laid dwn in Article 25 and a decisin pursuant t Articles 35 and 36 has nt yet been taken, that Member State may prvisinally restrict r prhibit making available n the market r use f that prduct n its territry. Submissin and validatin f New Applicatins fr Active Substances Under Article 7 f the BPR, the apprval f an active substance will be carried ut by the Agency: The applicant shall submit an applicatin fr apprval f an active substance, r fr making subsequent amendments t the cnditins f apprval f an active substance, t the Agency, infrming it f the name f the cmpetent authrity f the Member State that it prpses shuld evaluate the applicatin and prviding written cnfirmatin that that cmpetent authrity agrees t d 8 P a g e
s. That cmpetent authrity shall be the evaluating cmpetent authrity. The Agency means the Eurpean Chemicals Agency established by Regulatin (EC) N 1907/2006. The applicatin fr apprval f an active substance must meet certain requirements laid dwn in the BPR, including the submissin f a dssier and payment f a fee. The evaluatin f the applicatin in the United Kingdm will be carried ut by the Health and Safety Executive ( HSE ) 3 as the cmpetent authrity. The HSE will evaluate the applicatin within the timeframe and prcedures laid dwn by the BPR. Apprved active substances shall be included in a Unin list f apprved active substances. The Cmmissin shall keep the list up t date and make it electrnically available t the public. Unin authrisatin allws an applicatin t be made via a single authrisatin, aviding the need fr mutual recgnitin f a natinal authrisatin. Unin authrisatins are fr bicidal prducts with similar cnditins f use acrss the Unin (certain exceptins apply). Depending upn the prduct types, Unin authrisatin will be available in three different stages: Frm 1 September 2013 fr prduct types 1, 3, 4, 5, 18 and 19. Frm 1 January 2017 fr prduct types 2, 6 and 13. Frm 1 January 2020 nwards t the remaining prducts types 7, 8, 9, 10, 11, 12, 16 and 22. Prduct Types Under the BPR, bicidal prducts are classified int 22 bicidal prduct-types, gruped int fur main areas. It is wrth nting that preservatives fr fd and feedstck are nt within the scpe f the BPR 4. 3 In the UK 4 The full list f prduct types can be fund in Annex V f the BPR. 9 P a g e
Bicidal prducts intended t be used nt nly fr the purpses f this Regulatin, but als in cnnectin with medical devices, such as disinfectants used t disinfect surfaces in hspitals and medical devices, may pse risks ther than thse with which this Regulatin is cncerned. Therefre, such bicidal prducts shuld cmply, in additin t the requirements laid dwn in this Regulatin, with the relevant essential requirements set ut in Annex I t Cuncil Directive 90/385/EEC f 20 June 1990 n the apprximatin f the laws f the Member States relating t active implantable medical devices ( 1 ), Cuncil Directive 93/42/EEC f 14 June 1993 cncerning medical devices ( 2 ) and Directive 98/79/EC f the Eurpean Parliament and f the Cuncil f 27 Octber 1998 n in vitr diagnstic medical devices Therefre, the present Regulatin shuld nt apply t fd and feed used as repellents r attractants. Prduct Type MAIN GROUP 1: Disinfectants Examples These prduct-types exclude cleaning prducts that are nt intended t have a bicidal effect, including washing liquids, pwders and similar prducts. Prduct-type 1: Human hygiene Prducts in this grup are bicidal prducts used fr human hygiene purpses, applied n r in cntact with human skin r scalps fr the primary purpse f disinfecting the skin r scalp. Prduct-type 2: Disinfectants and algaecides nt intended fr direct applicatin t humans r animals Prducts used fr the disinfectin f surfaces, materials, equipment and furniture which are nt used fr direct cntact with fd r feeding stuffs. Usage areas include, inter alia, swimming pls, aquariums, bathing and ther waters; air cnditining systems; and walls and flrs in private, public, and industrial areas and in ther areas fr prfessinal activities. Prducts used fr disinfectin f air, water nt used fr human r animal cnsumptin, 10 P a g e
chemical tilets, waste water, hspital waste and sil. Prducts used as algaecides fr treatment f swimming pls, aquariums and ther waters and fr remedial treatment f cnstructin materials. Prducts used t be incrprated in textiles, tissues, masks, paints and ther articles r materials with the purpse f prducing treated articles with disinfecting prperties. Prduct-type 3: Veterinary hygiene Prduct-type 4: Fd and feed area Prducts used fr veterinary hygiene purpses such as disinfectants, disinfecting saps, ral r crpral hygiene prducts r with anti-micrbial functin. Prducts used t disinfect the materials and surfaces assciated with the husing r transprtatin f animals. Prducts used fr the disinfectin f equipment, cntainers, cnsumptin utensils, surfaces r pipewrk assciated with the prductin, transprt, strage r cnsumptin f fd r feed (including drinking water) fr humans and animals. Prducts used t impregnate materials which may enter int cntact with fd. Prduct-type 5: Drinking water MAIN GROUP 2: Preservatives Prducts used fr the disinfectin f drinking water fr bth humans and animals. Unless therwise stated these prducttypes include nly prducts t prevent micrbial and algal develpment. Prduct-type 6: Preservatives fr prducts during strage Prduct-type 7: Film preservatives 11 P a g e Prducts used fr the preservatin f manufactured prducts, ther than fdstuffs, feedingstuffs, csmetics r medicinal prducts r medical devices by the cntrl f micrbial deteriratin t ensure their shelf life. Prducts used as preservatives fr the strage r use f rdenticide, insecticide r ther baits. Prducts used fr the preservatin f films r catings by the cntrl f micrbial deteriratin r algal grwth in rder t prtect the initial prperties f the surface f materials r bjects such as paints, plastics, sealants,
wall adhesives, binders, papers, art wrks. Prduct-type 8: Wd preservatives Prducts used fr the preservatin f wd, frm and including the saw-mill stage, r wd prducts by the cntrl f wd-destrying r wd-disfiguring rganisms, including insects. This prduct-type includes bth preventive and curative prducts. Prduct-type 9: Fibre, leather, rubber and plymerised materials preservatives Prducts used fr the preservatin f fibrus r plymerised materials, such as leather, rubber r paper r textile prducts by the cntrl f micrbilgical deteriratin. This prduct-type includes bicidal prducts which antagnise the settlement f micr-rganisms n the surface f materials and therefre hamper r prevent the develpment f dur and/r ffer ther kinds f benefits. Prduct-type 10: Cnstructin material preservatives Prducts used fr the preservatin f masnry, cmpsite materials, r ther cnstructin materials ther than wd by the cntrl f micrbilgical, and algal attack. Prduct-type 11: Preservatives fr liquidcling and prcessing systems Prducts used fr the preservatin f water r ther liquids used in cling and prcessing systems by the cntrl f harmful rganisms such as micrbes, algae and mussels. Prducts used fr the disinfectin f drinking water r f water fr swimming pls are nt included in this prduct- type. Prduct-type 12: Slimicides Prducts used fr the preventin r cntrl f slime grwth n materials, equipment and structures, used in industrial prcesses, e.g. n wd and paper pulp, prus sand strata in il extractin. Prduct-type 13: Wrking r cutting fluid preservatives Prducts t cntrl micrbial deteriratin in fluids used fr wrking r cutting metal, glass r ther materials. 12 P a g e
MAIN GROUP 3: Pest cntrl Prduct-type 14: Rdenticides Prducts used fr the cntrl f mice, rats r ther rdents, by means ther than repulsin r attractin. Prduct-type 15: Avicides Prduct-type 16: Mlluscicides, vermicides and prducts t cntrl ther invertebrates Prducts used fr the cntrl f birds, by means ther than repulsin r attractin. Prducts used fr the cntrl f mlluscs, wrms and invertebrates nt cvered by ther prduct-types, by means ther than repulsin r attractin. Prduct-type 17: Piscicides Prducts used fr the cntrl f fish, by means ther than repulsin r attractin. Prduct-type 18: Insecticides, acaricides and prducts t cntrl ther arthrpds Prducts used fr the cntrl f arthrpds (e.g. insects, arachnids and crustaceans), by means ther than repulsin r attractin. Prduct-type 19: Repellents and attractants Prducts used t cntrl harmful rganisms (invertebrates such as fleas, vertebrates such as birds, fish, rdents), by repelling r attracting, including thse that are used fr human r veterinary hygiene either directly n the skin r indirectly in the envirnment f humans r animals. Prduct-type 20: Cntrl f ther vertebrates Prducts used fr the cntrl f vertebrates ther than thse already cvered by the ther prduct-types f this main grup, by means ther than repulsin r attractin. MAIN GROUP 4: Other bicidal prducts Prduct-type 21: Antifuling prducts Prducts used t cntrl the grwth and settlement f fuling rganisms (micrbes and higher frms f plant r animal species) n vessels, aquaculture equipment r ther structures used in water. Prduct-type 22: Embalming and taxidermist fluids Prducts used fr the disinfectin and preservatin f human r animal crpses, r parts theref. 13 P a g e
Submissin and Acceptance f Renewal Applicatins fr Active Substances Under Article 13 f the BPR, the renewal f the apprval f an active substance will be carried ut by the Agency: Applicants wishing t seek renewal f the apprval f an active substance fr ne r mre prduct-types shall submit an applicatin t the Agency at least 550 days befre the expiry f the apprval. Where there are different expiry dates fr different prduct-types, the applicatin shall be submitted at least 550 days befre the earliest expiry date. The evaluatin f the renewal applicatin will be carried ut by HSE within the timeframe and prcedures laid dwn by the BPR 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 Submissin and Acceptance f Applicatins An applicatin by r n behalf f an authrisatin hlder wishing t seek the renewal f a Unin authrisatin must be submitted t the Agency befre the expiry date f the authrisatin. The evaluatin f the applicatin will be carried ut by HSE within the timeframe and prcedures laid dwn by the BPR Submissin and Validatin f Applicatins Applicants wishing t apply fr Unin authrisatin in accrdance with Article 42(1) shall submit an applicatin t the Agency, including a cnfirmatin that the bicidal prduct wuld have similar cnditins f use acrss the Unin, infrming the Agency f the name f the cmpetent authrity f the Member State that they prpse shuld evaluate the applicatin and prviding written cnfirmatin that the 14 P a g e
cmpetent authrity has agreed t d s. The evaluatin f the applicatin will be carried ut by HSE within the timeframe and prcedures laid dwn by the BPR Authrisatin thrugh Mutual Recgnitin in Sequence All Member States receiving applicatins fr mutual recgnitin f a natinal authrisatin fr a bicidal prduct shall authrise the bicidal prduct under the same terms and cnditins as the natinal authrisatin Applicants wishing t use the mutual recgnitin in sequence fr the natinal authrisatin f a bicidal prduct already granted in anther Member State, in accrdance with Article 17, have t submit an applicatin t each f the cmpetent authrities f the Member States cncerned. Authrisatin thrugh Mutual Recgnitin in Parallel Applicants wishing t use the mutual recgnitin in parallel fr a bicidal prduct which has nt yet been authrised in accrdance with Article 17 in any Member State, must submit the applicatin t the cmpetent authrity f the Member State f its chice. Applicants may apply fr Unin authrisatin fr bicidal prducts which have similar cnditins f use acrss the Unin with the exceptin f bicidal prducts that cntain active substances that fall under Article 5 f a particular prduct type. The Unin authrisatin may be granted frm 1 September 2013, fr bicidal prducts cntaining ne r mre new active substances and bicidal prducts f specific prduct-types. In January 2017 and 2020, Unin authrisatin may be granted fr ther bicidal prduct types. Classificatin, Packaging and Labelling f Bicidal Prducts All authrisatin hlders must ensure that their bicidal prducts are classified, packaged and labeled: 15 P a g e
In accrdance with the apprved summary f bicidal prduct characteristics, in particular the hazard statements and the precautinary statements, as referred t in pint (i) f Article 22(2), and with Directive 1999/45/EC and, where applicable, Regulatin (EC) N 1272/2008. In additin: Prducts which may be mistaken fr fd, including drink, r feed shall be packaged t minimise the likelihd f such a mistake being made. If they are available t the general public, they must cntain cmpnents t discurage their cnsumptin and, in particular, shall nt be attractive t children. Authrisatin hlders must ensure that labels are nt misleading in respect f the risks frm the prduct t human health, animal health r the envirnment r its efficacy; Authrisatin hlders must ensure that labels d nt mentin the indicatins lw-risk bicidal prduct, nn-txic, harmless, natural, envirnmentally friendly, animal friendly r similar indicatins. The label must shw clearly and indelibly specific infrmatin as laid dwn by the BPR: The identity f every active substance and its cncentratin in metric units; The nanmaterials cntained in the prduct, if any, and any specific related risks, and, fllwing each reference t nan materials, the wrd nan in brackets; The authrisatin number allcated t the bicidal prduct by the cmpetent authrity r the Cmmissin; The name and address f the authrisatin hlder etc. Where due t the size f the bicidal prduct specific infrmatin cannt 16 P a g e
be included in the label, this may be indicated n the packaging r n an accmpanying leaflet integral t the packaging. Member States may require: The prvisin f mdels r drafts f the packaging, labelling and leaflets; That bicidal prducts made available n the market in their territries be labelled in their fficial language r languages. Register fr Bicidal Prducts An applicatin fr the authrisatin f bicidal prducts shuld be submitted via he Register fr Bicidal Prducts. Frm 1 September 2013, ECHA will be respnsible fr crdinating the evaluatin f applicatins. The Agency is therefre bliged t maintain the Register fr Bicidal Prducts. Applicants fr the authrisatin f bicidal prducts: Shuld submit applicatins and data fr all prcedures cvered by the BPR. The Agency will then check that crrect frmat was fllwed and ntify the relevant cmpetent authrity accrdingly withut delay r reject the applicatin; Once the applicatin has been validated r accepted by the HSE in this case, the details shall be made available via the Register fr Bicidal Prducts t all ther cmpetent authrities and t the Agency; The HSE will update the infrmatin in the Register fr Bicidal Prducts relating t bicidal prducts which it has authrised r refused, amended, renewed r cancelled; The Cmmissin shall update the infrmatin relating t bicidal prducts which have been authrised in the Unin r fr which a Unin authrisatin has been refused, amended, renewed r cancelled. 17 P a g e
Making available n the Market and Use f Bicidal Prducts Under Article 17 f the BPR, there are sme imprtant pints t nte: Bicidal prducts shall nt be made available n the market r used unless authrised in accrdance with the BPR. Applicatins fr authrisatin shall be made by, r n behalf f, the prspective authrisatin hlder. Applicatins fr natinal authrisatin in a Member State shall be submitted t the cmpetent authrity f that Member State i.e. the HSE. Applicatins fr Unin authrisatin shall be submitted t the Agency. An authrisatin may be granted fr a single bicidal prduct r a bicidal prduct family. An authrisatin shall be granted fr a maximum perid f 10 years. Bicidal prducts shall be used in cmpliance with the terms and cnditins f the authrisatin stipulated in accrdance with Article 22(1) and the labelling and packaging requirements laid dwn in Article 69; Instructins fr safe dispsal f the prduct and its packaging; The cnditins fr strage and shelf-life f the bicidal prduct under nrmal cnditins f strage; Any ther infrmatin abut the bicidal prduct. Applicants wishing t apply fr a natinal authrisatin in accrdance with Article 17 shall submit an applicatin t the HSE. Placing n the Market f Treated Articles Article 58 f the BPR applies exclusively t treated articles that are nt bicidal 18 P a g e
prducts. It des nt apply t treated articles where the sle treatment t be undertaken is the fumigatin r disinfectin f premises r cntainers used fr strage r transprt and where n residues are expected t remain frm such treatment. Therefre, a treated article cannt be placed n the market unless all active substances cntained in the bicidal prducts treating the article are included in the Annex t the BPR fr this prduct-type and any cnditins r restrictins specified that are specified in the Annex are met. Labelling f treated articles must cmply with the prvisins f the BPR. Cntent f an Authrisatin An authrisatin fr a bicidal prduct shall include the fllwing: Stipulatin f the terms and cnditins fr making the bicidal prduct available n the market; Use f the single bicidal prduct r the bicidal prduct family; Summary f the bicidal prduct characteristics including the fllwing infrmatin: The trade name f the bicidal prduct; The name and address f the authrisatin hlder; The date f authrisatin and its expiry; The authrisatin number f the bicidal prduct; Qualitative and quantitative cmpsitin in terms f the active substances and nn-active substances; The manufacturers f the bicidal prduct (names and addresses including lcatin f manufacturing sites); The manufacturers f the active substances (names and addresses 19 P a g e
including lcatin f manufacturing sites); The type f frmulatin f the bicidal prduct; The hazard and precautinary statements; The prduct-type; The target harmful rganisms; The applicatin dses and instructins fr use; The categries f users; The particulars f likely direct r indirect adverse effects. Advertising under the BPR An advertisement is defined as a means f prmting the sale r use f bicidal prducts by printed, electrnic r ther media. Article 72 deals with advertising. A bicidal prduct hlder must cmply with the prvisins f the Rregulatin n classificatin, labelling and packaging ("CLP Regulatin") and that f the BPR. Article 72 states that: Any advertisement fr bicidal prducts shall, in additin t cmplying with Regulatin (EC) N 1272/2008, include the sentences Use bicides safely. Always read the label and prduct infrmatin befre use.. The sentences shall be clearly distinguishable and legible in relatin t the whle advertisement. Advertisers may replace the wrd bicides in the prescribed sentences with a clear reference t the prduct-type being advertised. Advertisements fr bicidal prducts shall nt refer t the 20 P a g e
prduct in a manner which is misleading in respect f the risks frm the prduct t human health, animal health r the envirnment r its efficacy. In any case, the advertising f a bicidal prduct shall nt mentin lw-risk bicidal prduct, nn-txic, harmless, natural, envirnmentally friendly, animal friendly r any similar indicatin. Obligatin fr Ntificatin f Unexpected r Adverse Effects Once a bicidal prduct hlder becmes aware f infrmatin that may affect the authrisatin f an authrised bicidal prduct r its active substance(s), the hlder f the authrisatin must prmptly ntify the HSE and the Agency r, in the case f a Unin authrisatin, the Cmmissin and the Agency. In particular, the fllwing must be ntified: New data r infrmatin n the adverse effects f the active substance r bicidal prduct fr humans, in particular vulnerable grups, animals r the envirnment; Any data indicating the ptential f the active substance fr the develpment f resistance; New data r infrmatin indicating that the bicidal prduct is nt sufficiently effective. Data Prtectin With regard t the prtectin f data held by the HSE r the Agency, such data shall nt be used by the HSE r the Agency fr the benefit f a subsequent applicant, except where: The subsequent applicant submits a letter f access; r The relevant time limit fr data prtectin has expired. When submitting data t the HSE r t the Agency under the BPR, the applicant must: Indicate the name and cntact details f the data wner fr all data submitted; 21 P a g e
Specify whether it is the data wner/hlds a letter f access. Applicant shall, withut delay, infrm the cmpetent authrity r the Agency abut any changes t the wnership f the data; The BPR prvides fr prtectin f data up t a maximum limit. Once the prtectin expires, it is lst. Existing active substance The prtectin perid fr data submitted with a view t the apprval f an existing active substance shall end 10 years frm the first day f the mnth fllwing the date f adptin f a decisin in accrdance with Article 9 n the apprval f the relevant active substance fr the particular prduct-type. New active substance The prtectin perid fr data submitted with a view t the apprval f a new active substance shall end 15 years frm the first day f the mnth fllwing the date f adptin f a decisin in accrdance with Article 9 n the apprval f the relevant active substance fr the particular prduct-type. Renewal r review f the apprval f an active substance The prtectin perid fr new data submitted with a view t the renewal r review f the apprval f an active substance shall end five years frm the first day f the mnth fllwing the date f the adptin f a decisin in accrdance with Article 14(4) cncerning the renewal r the review. 22 P a g e
A bicidal prduct cntaining nly existing active substances The prtectin perid fr data submitted with a view t the authrisatin f a bicidal prduct cntaining nly existing active substances shall end 10 years frm the first day f the mnth fllwing the first decisin cncerning the authrisatin f the prduct taken in accrdance with Article 30(4), Article 34(6) r Article 44(4). A bicidal prduct cntaining a new active substance The prtectin perid fr data submitted with a view t the authrisatin f a bicidal prduct cntaining a new active substance shall end 15 years frm the first day f the mnth fllwing the first decisin cncerning the authrisatin f the prduct taken in accrdance with Article 30(4), Article 34(6) r Article 44(4). renewal r amendment f the authrisatin f a bicidal prduct The prtectin perid fr new data submitted with a view t the renewal r amendment f the authrisatin f a bicidal prduct shall end five years frm the first day f the mnth fllwing the decisin cncerning the renewal r amendment f the authrisatin. Data Sharing The BPR states that in rder t avid animal testing, testing n vertebrates shall be undertaken nly as a last resrt. Testing n vertebrates shall nt be repeated fr the purpses f the BPR. Therefre, any persn intending t perfrm tests r studies in the case f data invlving tests n vertebrates must submit a written request t the Agency t determine whether such tests r studies have already been submitted t the Agency 23 P a g e
r t HSE in cnnectin with a previus applicatin. The Agency shall verify whether such tests r studies have already been submitted. Where such tests r studies have already been submitted t the Agency r t a cmpetent authrity in cnnectin with a previus applicatin, under BPR r Directive 98/8/EC, the Agency shall, withut delay, cmmunicate the name and cntact details f the data submitter and data wner t the prspective applicant. T encurage the develpment f new active substances and bicidal prducts cntaining them, it is necessary t prvide fr a perid f prtectin with respect t the prprietary infrmatin submitted in supprt f the apprval f such active substances r the authrisatin f bicidal prducts cntaining them which is lnger than the perid f prtectin fr infrmatin cncerning existing active substances and bicidal prducts cntaining them. Parallel Trade Accrding t Article 53,1, at the request f the applicant the HSE shall grant a parallel trade permit fr a bicidal prduct that is authrised in anther Member State t be made available n the market and used in the Member State f intrductin, if it determines that the bicidal prduct is identical t a bicidal prduct already authrised in the Member State f intrductin. There is a fee payable. A cmpetent authrity f a Member State ( Member State f intrductin ) shall, at the request f the applicant, grant a parallel trade permit fr a bicidal prduct that is authrised in anther Member State ( Member State f rigin ) t be made available n the market and used in the Member State f intrductin, if it determines in accrdance with paragraph 3 that the bicidal prduct is identical t a bicidal prduct already authrised in the Member State f intrductin ( the reference prduct ). The applicant wh intends t place the bicidal prduct n the market in the Member State f intrductin shall submit the applicatin fr a parallel trade permit t the cmpetent authrity f the Member State f intrductin. The HSE may request additinal infrmatin necessary t determine whether the prducts are identical. There are specified timeframes fr the delivery f this infrmatin. 24 P a g e
A bicidal prduct shall be cnsidered as identical t the reference prduct nly if all the fllwing cnditins are met: (a) they have been manufactured by the same cmpany, by an assciated undertaking r under license in accrdance with the same manufacturing prcess; (b) they are identical in specificatin and cntent in respect f the active substances and the type f frmulatin; (c) they are the same in respect f the nn-active substances present; and (d) they are either the same r equivalent in packaging size, material r frm, in terms f the ptential adverse impact n the safety f the prduct with regard t human health, animal health r the envirnment. 4.An applicatin fr a parallel trade permit shall include the fllwing infrmatin and items: (a) name and authrisatin number f the bicidal prduct in the Member State f rigin; (b) name and address f the cmpetent authrity f the Member State f rigin; (c) name and address f the authrisatin hlder in the Member State f rigin; (d) riginal label and instructins fr use with which the bicidal prduct is distributed in the Member State f rigin if it is cnsidered as necessary fr the examinatin by the cmpetent authrity f the Member State f intrductin; (e) name and address f the applicant; (f) name t be given t the bicidal prduct t be distributed in the Member State f intrductin; (g) a draft label fr the bicidal prduct intended t be made available n the market in the Member State f intrductin in the fficial language r languages f the Member State f intrductin, unless that Member State prvides therwise; (h) a sample f the bicidal prduct which is intended t be intrduced if it is cnsidered as necessary by the cmpetent authrity f the Member State f intrductin; (i) name and authrisatin number f the reference prduct in the Member State f intrductin. Under Article 95 (3) f the BPR, after the 1st September 2015, bicidal prducts cannt be made available n the EU market if the active substance manufacturer/imprter is nt n the list. 25 P a g e
The authr is Dr Rsanna Cper f RT Cpers Slicitrs. She is an expert in all aspects f regulatry law. Dr Cper is a chartered chemist and a fellw f the Ryal Sciety f Chemistry. She may be cntacted n +44 (0) 207 488 9947 r by email: enquiries@rtcpersslicitrs.cm. Fr mre infrmatin n the services prvided by RT Cpers n regulatry law, visit http://www.rtcpers.cm/regulatrylaw.php and www.rtcpers.cm/practice_bicides.php. Tags RT Cpers Slicitrs and ur bicide lawyers prviding regulatry law and bicides legal advice n bicidal prduct regulatin including bicidal prduct authrisatin, treated articles regulatin, bicides, pesticides as well as the classificatin, labelling and packaging f bicidal prducts, antibacterial, disinfectants, insecticides, veterinary prducts, antimicrbial prducts, furniture painted with wd preservatives and prduct regulatin 26 P a g e