Formulated Biocidal Products Under the BPR

Formulated Biocidal Products Under the BPR Dr. Anna Gergely Director, EHS Regulatory Steptoe, Brussels Office June 14, 2012 www.steptoe.com

Presentation Overview Two-step procedure for formulated product approval Active substances authorization Biocidal products authorization Mutual recognition of product authorization: in parallel in sequence Derogation Coordination Group Transitional measures for the Review Program www.steptoe.com 2

Active Substance Active substance substance or a micro-organism that has an action on or against harmful organisms (Article 3(1)(c)) Harmful organism an organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment (Article 3(1)(g)) www.steptoe.com 3

Active Substance Exclusion Criteria Exclusion Criteria Article 5 (New) some active substances are generally excluded (CMR, PBT, vpvb, endocrine disruptors) BUT: could be approved exceptionally for 5 years if risk is negligible due to controlled exposure; OR evidence demonstrates that the active is essential; OR disproportionate negative societal impact of non-approval combination of hazard and risk considerations www.steptoe.com 4

Active Substance Candidate for Substitution Candidates for substitution Article 10 (New) If: any of the exclusion criteria, respiratory sensitizers, low ADI/AOEL, specific exposure concerns approval considers ECHA consultation on substitutes maximum 7 years approval/renewal, earmarked as candidate for substitution www.steptoe.com 5

Active Substance Approval Application made to ECHA Proposing Member State to conduct the assessment (with MS s CA agreement) ECHA adopts opinion and Commission takes a decision active valid in EU/EEA Approval lasts: 10 years maximum 5 or 7 years where candidate for substitution Commission may review active approval at any time when significant safety concerns (cancellation or amendment) www.steptoe.com 6

Biocidal Products Article 3(1)(a) (New extended definition) Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action Any substance or mixture generated from substances or mixtures which are not themselves biocidal products under the first paragraph to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action A treated article that has a primary biocidal function shall be considered a biocidal product www.steptoe.com 7

Biocidal Product Types Group 1* Disinfectants Group 2 Preservatives Group 3 Pest Control Group 4 Other biocides PT1: Human hygiene PT2: Disin fectants and algaecides not intended for direct application to humans or animals PT3: Veterinary hygiene PT4: Food and feet area PT5: Drinking water *Excludes clearing products that are not intended to have a biocidal effect, including washing liquid powder and similar products. PT6: Preservatives for products during storage PT7: Film preservatives PT8: Wood Preservatives PT9: Fiber, leather, rubber and polymerized materials preservatives PT10: Constructions materials preservatives PT11: Preservatives for liquid-cooling and processing systems PT12: Slimicides PT13: Working or cutting fluid preservatives PT14: Rodenticides PT15: Avicides PT16: Molluscides, vermicides, and products to control other vertebrates PT17: Piscicides PT18: Insecticides, acaricides, and products to control other arthropods PT19: Repellants and attractants PT20: Control of other vertebrates (Previously PT 23) PT20: Preservatives for food or foodstocks* PT21: Antifouling products PT22: Embalming and taxidermist fluids * Because now covered by specific EU legislation www.steptoe.com 8

Conditions for Authorization Conditions for authorization (Article 19) active substances are approved for the relevant product-type and any conditions specified are met; the biocidal product, when used as authorized fulfills the following criteria: (i) the biocidal product is sufficiently effective; (ii) no unacceptable effects on the target organisms (unacceptable resistance, crossresistance or unnecessary suffering and pain for vertebrates); (iii) the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on human or animal health, including that of vulnerable groups directly or through drinking water, food, feed, air, or through other indirect effects; (iv) the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations: the fate and distribution of the biocidal product in the environment; contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation; the impact of the biocidal product on non-target organisms; the impact of the biocidal product on biodiversity and the ecosystem; www.steptoe.com 9

Conditions for Authorization (cont.) the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorized, can be determined according to the relevant requirements in Annexes II & III; the physical and chemical properties of the biocidal product have been determined and deemed acceptable for the purposes of the appropriate use and transport of the product; where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with [existing regulations] where nanomaterials are used, the risk to the environment and to health has been assessed separately. www.steptoe.com 10

Conditions for Authorization (cont.) Evaluation Criteria Realistic worst case use conditions (also for treated articles) Consequences of use and disposal Cumulative effects Synergistic effects Authorization only granted for uses where required information was provided Excluded from authorization for the general public: CMRs, toxic (1,2 or 3), PBT, vpvb, ED, dev. neurotoxic or immunotoxic effects unless disproportionate negative impacts www.steptoe.com 11

Biocidal Product MS Authorization Member State Authorizations (Article 29) Submit application to Member State Competent Authority (validate within 30 days after fees paid) Member State conducts assessment and drafts assessment report (within 365 days + max 180 days suspension if further information is requested) Approval valid in relevant Member State only www.steptoe.com 12

Biocidal Products EU authorization Union Authorization phased in by PT until January 1, 2020 (Articles 41-44) (New) Allowed for products with similar conditions of use (Commission guidance should clarify uses) Not available for actives under Art 5 Exclusion criteria and to PT 14,15,17,20 and 21 Dossier submitted to ECHA; evaluated by a Member State proposed by the applicant ECHA adopts opinion and Commission takes a decision product valid in EU/EEA 10 years maximum approval www.steptoe.com 13

EU authorization by product type (Article 42) NOT eligible for Union authorization From 1 September 2013 From 1 January 2017 From 1 January 2020 PT 14: Rodenticides PT 15: Avicides PT 17: Piscicides PT 20: Control of other vertebrates PT 21: Antifouling products PT 1: Human hygiene PT 3: Veterinary hygiene PT 4: Food and feed area PT 5: Drinking water PT 18: Insecticides, acaricides and products to control other arthropods PT 19: Repellents and attractants PT 2: Disinfectants and algaecides not intended for direct application to humans or animals PT 6: Preservatives for products during storage PT 13: Working or cutting fluid preservatives PT 7: Film preservatives PT 8: Wood preservatives PT 9: Fibre, leather, rubber, and polymerized materials preservatives PT 10: Construction material preservatives PT 11: Preservatives for liquid-cooling and processing systems PT 12: Slimicides PT 16: Molluscicides, vermicides, and products to control other invertebrates PT 22: Embalming and taxidermist fluids www.steptoe.com 14

Simplified authorization for low risk products Simplified Authorization (Article 25) if: All active substances in the product are in Annex I and satisfy any restriction therein No substance of concern No nanomaterials Product is sufficiently effective Handling and use do not require personal protective equipment Simplified procedure, reduced info requirements (does not have to meet Article 19 authorization conditions) Member State conducts evaluation Union-wide authorization, but notification required www.steptoe.com 15

Biocidal Products containing candidates for substitution Products containing candidates for substitution (Article 23) (New): Comparative assessment during authorization and renewal of product Prohibit or restrict marketing or use if lower risk effective substitutes, no significant economic/practical disadvantages, low resistance risk (4 years phasing out) If no appropriate substitute exists, maximum 5 years product authorization/renewal www.steptoe.com 16

Mutual Recognition (MR) Mutual recognition of national biocidal product authorization (Articles 32-39) unnecessary for Simplified and Union product authorization Requested by registrant or official or scientific bodies In sequence or in parallel Derogations allowed Coordination group www.steptoe.com 17

MR in sequence In sequence (Art. 33) after national authorization in a MS per Art. 17 After applicant pays fees, MS have 30 days to validate application After validating, MS have 90 days to agree on summary of biocidal product characteristics and those in agreement shall record their agreement. Within 30 days of reaching agreement, MS shall authorize BP in conformity with the agreed summary of biocidal product characteristics. MS who doesn t agree with agreed summary doesn t sign www.steptoe.com 18

MR in parallel In parallel (Art. 34) while applying for first national authorization (New) When applying for mutual recognition in parallel, all concerned MS must review the draft assessment report prepared by reference MS MS have 90 days to agree on summary of biocidal product characteristics and those in agreement shall record their agreement. Within 30 days of reaching agreement, MS shall authorize BP in conformity with the agreed summary of biocidal product characteristics. MS who don t agree with agreed summary don t sign www.steptoe.com 19

MR Derogation Member States may refuse to authorize MR or may adjust terms, provided that such a measure may be justified on grounds of: Protection of the environment Public policy or public security Protection of health and life of humans, particularly of vulnerable groups,or of animals or plants Protection of national treasures, possessing artistic, historic, or archeological value Target organisms not present in harmful quantities Where product contains an active substance meeting exclusion criteria or that is a candidate for substitution www.steptoe.com 20

MR Derogation Procedure Member State shall communicate to applicant detailed statement of the grounds for seeking derogation and shall seek to reach an agreement with the applicant. If after 60 days unable to reach agreement: Member State informs the Commission Commission may ask ECHA for opinion on the scientific or technical question, or simply adopt a decision If Commission does not adopt decision within 90 days, derogation may be implemented If Commission issues decision, Member State concerned shall take necessary measures to comply within 30 days www.steptoe.com 21

MR- Coordination Group Coordination Group created to examine whether a biocidal product for which an application for MR has been made meets Article 19 authorization requirements (New) All Members States and Commission entitled to participate ECHA is secretariat MS who believe authorization does not meet Article 19 shall send detailed explanation of points of disagreement and reasons Group has 60 days to agree If after 60 days unable to reach agreement: Group refers unresolved objection to Commission Commission may ask ECHA for opinion on the scientific or technical question, or may ask applicant for written comments Commission shall adopt decision by implementing acts www.steptoe.com 22

Comparative Table: Procedures (I) ACTIVE SUBSTANCE APPROVAL FOR SPECIFIED PT NATIONAL BIOCIDAL PRODUCT AUTHORIZATION SIMPLIFIED BIOCIDAL PRODUCT AUTHORIZATION PRODUCT MUTUAL RECOGNITION IN SEQUENCE PRODUCT MUTUAL RECOGNITION IN PARALLEL UNION AUTHORIZATION OF BIOCIDAL PRODUCTS MAXIMUM APPROVAL PERIOD (YEARS) 10 (5 for excluded substances, 7 for candidates for substitution) 10 (5 if contains candidate for substitution) 10 (5 if contains candidate for substitution) 10 (5 if contains candidate for substitution) 10 (5 if contains candidate for substitution) 10 (5 if contains candidate for substitution) CONTENTS OF APPLICATION Dossier for active and representative biocidal product (potential data waiver/adaptation) Support for exceptional approval of excluded substances -Dossier/LoA for product and each active (potential data waiver/adaptation) -Summary of product characteristics in appropriate language(s) -Confirmation that not applied to other CA -Summary of product characteristics -Efficacy data (potential data waiver/adaptation) -Information evidencing eligible for simplified procedure in appropriate language(s) Translation of national authorization granted in reference MS into relevant official languages To chosen evaluating CA ( reference MS ): -As for national or simplified product authorization, as appropriate -List of other MSs where national authorization sought To other MSs where national authorization sought: -Identity of reference MS and other MSs where national authorization sought -Summary of product characteristics in MS required languages -Dossier/LoA for product and each active (potential data waiver/adaptation) -Summary of product characteristics -Confirmation of similar conditions of use across Union in appropriate language(s) APPLICATION SUBMITTED TO ECHA, with confirmation of evaluating CA Application accepted on receipt of fee within 30 days of informing applicant Chosen CA where want to market product Application accepted on receipt of fee within 30 days of informing applicant ECHA, with confirmation of evaluating CA Application accepted if fee received within 30 days of informing applicant of fee Each CA of countries (other than reference MS) where want to market Application accepted if receives fee within 30 days of informing applicant Simultaneously to reference MS and other MSs concerned (see above) Application accepted if fee received within 30 days of informing applicant ECHA, with confirmation of which CA has agreed to evaluate Application accepted on receipt of fee within 30 days of informing applicant VALIDATION BY Chosen CA within 30 days of ECHA acceptance Applicant to provide missing information within normally max 90 days Fee payable to CA within 30 days of informing applicant Chosen CA within 30 days of acceptance Decline to evaluate if same product/use already subject of authorization application with another authority Applicant to provide missing information within normally max 90 days No formal validation stage Each CA within 30 days of its acceptance Evaluating CA ( reference MS ) within 30 days of its acceptance Applicant to provide missing information normally within max 90 days Chosen CA within 30 days of ECHA acceptance subject to payment of CA fee Applicant to provide missing information normally within max 90 days www.steptoe.com 23

Comparative Table: Procedures (II) ACTIVE SUBSTANCE APPROVAL FOR SPECIFIED PT NATIONAL BIOCIDAL PRODUCT AUTHORIZATION SIMPLIFIED BIOCIDAL PRODUCT AUTHORIZATION PRODUCT MUTUAL RECOGNITION IN SEQUENCE PRODUCT MUTUAL RECOGNITION IN PARALLEL UNION AUTHORIZATION OF BIOCIDAL PRODUCTS EVALUATION BY Chosen CA within 365 days of validation (or longer where further info required) Sends assessment report and conclusions to ECHA, taking account written comments from applicant during 30 day consultation period ECHA prepare and submit approval opinion to Commission within 270 days of receiving evaluation conclusions Chosen CA within 365 days of validation (or longer where further info required) Applicant to provide missing information within normally max 180 days Reduced evaluation by chosen CA ( verification of eligibility for simplified authorization) within 90 days of accepting application (or longer where further information required) Applicant to provide missing information within normally max 90 days CAs agree summary of product characteristics within 90 days of validation and record agreement in Register for Biocidal Products Coordination group (including applicant) and Commission resolution procedure if MS objection that safety authorization conditions not met Commission resolution procedure (including applicant) for mutual recognition derogation (public policy, public security, protection of environment, etc.) Evaluating CA ( reference MS ) within 365 days of validation Same coordination and resolution procedures as per in sequence Drafts assessment report, conclusions and reasons for granting or refusing authorization Send assessment report and summary of product characteristics to other MSs and applicant Other MSs CAs to agree summary of biocidal product characteristics within 90 days of receipt of report and record agreement in Register for Biocidal Products Chosen CA within 365 days of validation of application Applicant to provide missing information within normally max 180 days Applicant written comments on evaluation conclusions during 30 day period Chosen CA send assessment report and conclusions to ECHA, taking into account applicant comments ECHA prepare and submit to Commission opinion on authorization of product within 180 days of receipt (including any conditions on marketing or use) Reference MS to enter report and summary and any conditions on marketing and use in Register APPROVAL/NON- APPROVAL Commission adopt approval Regulation or non-approval decision Approved substances in public Union list of authorized active substances Chosen CA: - drafts assessment report with conclusions and reasons for granting or refusing authorization; - send electronic copy to applicant requesting comments within 30 days; - finalizes report taking account of conclusions. Provided eligible, chosen CA must authorize within 90 days of acceptance of application or of submission of additional information requested by applicant Each CA to authorize biocidal product within 30 days of agreement on summary and in conformity with summary In absence of agreement between all CAs, CAs agreeing to summary may authorize product All relevant MSs to authorize biocidal product within 30 days of agreement on summary and in conformity with summary If absence of agreement between all CAs, those CAs agreeing to summary may authorize product Commission authorization approval Regulation or nonapproval decision on receipt of ECHA opinion Commission can require conditions particular to certain MS territory or exclude a certain territory on MS derogation request www.steptoe.com 24

Transitional Procedures Active Substances Incomplete evaluation of active substance will be completed according to BPR: applicant able to submit further info to address new requirements excluded or candidate? but delays to review of existing active substances? New role of ECHA Biocidal Products Committee: evaluation coordination and technical support of MSs and Commission for active dossiers submitted post September 1, 2012 for earlier incomplete BPD dossiers, evaluation coordination with technical support from January 1, 2014 Existing actives review completion target of May 2014 very likely extended under BPR Deadlines for withdrawal following active non-approval or dossier rejection for approved active product authorization application in order to stay on market product dossier submission MS decision of submission www.steptoe.com 25

Transitional Procedures Biocidal Products Authorized products remain on market until authorization expiry/cancellation (subject to BPR from September 1, 2013) Incompletely evaluated product dossiers subject to BPD, except: BPR authorization procedure if excluded active comparative assessment procedure if contains candidate active applicants able to submit further info in these cases Biocidal products not expressly under BPD (in situ products, dual use, treated articles with a primary biocidal function etc.): may stay on market until product authorization decision provided application submitted by September 1, 2017 www.steptoe.com 26

Transitional Procedures free rider problem EU M/Is of actives and importers of products placed on EU market must submit active dossier or LoA to ECHA from September 1, 2015: active (or product) supplier must be on published source list (1 year existing stocks phase out period) exceptions for low risk Annex I actives end to free riding non-participants in existing active review www.steptoe.com 27

Questions? www.steptoe.com 28