A Practical Introduction to the BPR: Overview Darren Abrahams - - PowerPoint PPT Presentation
A Practical Introduction to the BPR: Overview Darren Abrahams Partner Biocides Europe 2015 - 18th Annual European Conference Pre-Conference Workshop 24 November 2015 Content 1. A Brief Introduction of Steptoe 2. BPR Main Principles &
Biocides Europe 2015 - 18th Annual European Conference Pre-Conference Workshop 24 November 2015
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Rockville* Century City Los Angeles Phoenix Palo Alto Chicago New York Washington, DC London Brussels Beijing
* Complex Litigation & Discovery Center
Regulation, Enforcement & Public Policy Commercial Litigation & Arbitration Transactions & Tax
(Incl. Food & Food Contact)
Policy
Enforcement
Compliance
Investment
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Plant Protection Products Directive 91/414 Biocidal Products Directive 98/8 REACH Regulation 1907/2006 Plant Protection Products Regulation 1107/2009 Biocidal Products Regulation 528/2012 Date of entry into force Date of entry into force 1-Sep-13 1-Jun-07 14-Dec-09 14-May-98 26-Jul-91
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A substance or microorganism including a virus or a fungus having general or specific action on or against harmful organisms. A substance or a microorganism that has an action on or against harmful organisms.
Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or
any harmful organism by chemical or biological means. 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 do not themselves fall under the first indent, 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.
None Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.
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‘primary biocidal function’)
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and algaecides not intended for direct application to humans
hygiene
area
products during storage
rubber and polymerized materials preservatives
materials preservatives
liquid-cooling and processing systems
fluid preservatives
vermicides, and products to control
acaricides, and products to control
and attractants
(previously PT23)
for food or feedstocks*
products
taxidermist fluids
now covered by specific EU legislation
cleaning products that are not intended to have a biocidal effect, including washing liquid, powder and similar products.
approval of last AS
making it necessary to change a BP Prohibition on the market
Use of stocks Approval of an AS for a product- type (« PT »)
application for associated BP (including MR)
Beginning of submission of dossier / LoA by by AS/BP suppliers to be listed on the AS list (+substance generating AS) as AS dossier submitter or AS/PT list
Prohibition on the market of BP consisting
generating an AS for which the AS supplier
not listed in the BPR, except if all AS listed in Annex I
(Article 95)
Use of stocks of all BP where no product supplier is listed
(Article 95 §6) Application rejected or not approved after 1
180 days
Prohibition on the market
Review programme of existing AS
subject to an open-ended extension (Article 89 §1) 31 Dec,
2025
1 Sept,
2016
1 Sept,
2015
1 Sept,
2013
Biocidal products (« BP ») containing existing active substances (« AS ») which have been / are being evaluated can remain on the national market (if BP application submitted before the AS approval date)
(Article 89 §2 to 4) 31 Dec,
2024
(Reg. 736/2013) 1 Sept,
2017
yet evaluated remain subject to the BPD [but see Articles 5(1) and 10 of the BPR] (Article 91)
get their BPR authorisation
delivered prior to that date remain valid until their expiration date but are subject to the BPR
(Article 92)
Prohibition on the market of TA containing AS that are neither under the review programme / nor authorised / for which no application has been filed by 1 Sept, 2016
(Article 94 ) AS dossier submitted before 1 Sept 2013 but not yet evaluated will be evaluated in accordance
the BPD dossier with possible additional information (Article 90 §2)
AS not approved Last submission date for approbation dossier of AS/PT combination which Newly Covered BP* consist of, contain or generate
(Article 93)
* ‘Newly Covered BP’: Biocidal products outside the scope of the BPD, covered by the BPR and consisiting of, containing or generating AS available on the market on 1 September 2013 180 days 365 days Approval of an AS for a given PT & deadline for submission of application for associated BP Up to 3 years
for approval of associated BP
Up to 3 years
For authorisation of associated BP
180 days 365 days
Approval of the last AS to be approved AS not approved
12 months
Prohibition on the market
3 years
BP subject to the BPR
18 months
Use of stocks
12 months
Prohibition on the market
Choice of MS to apply their own frameworks to the making available on the market and use of BP containing (1) existing AS which have been or are being evaluated and (2) approved AS and AS as defined in (1)
(Article 89 §2)
18 months
Use of stocks
approval of last AS
making it necessary to change a BP Prohibition on the market
Use of stocks
End of use and of making available on the market of Newly Covered BP which consists of, contains or generates AS for which no dossier has been submitted by 1 Sept 2016 (Article 93 (b))
conditions
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– Applies to AS for which draft CA assessment report has been issued after 01.09.2013
– active substances that meet the criteria for CMR (1A or 1B), PBT or ED (REACH criteria) – unless negligible risk under realistic worst case conditions of use; or, essential; or, disproportionate negative impact on society (socio-economic analysis) substitution
– e.g. exclusion criteria, respo. sensitiser, 2 of PBT criteria, significant proportion of impurities or non-active isomers – public consultation 60 days (opportunity for interested 3rd parties) – approval not exceeding 7 years & identified as such in Union list of approved AS
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Priority
Existing active substances for product types eCA has to submit assessment report to ECHA by The BPC* must start to prepare its opinion (for submission to Commission) by
1st priority list
2nd priority list
3rd priority list
4th priority list
5th priority list
6th priority list
* The Agency shall submit the opinion to the Commission within 270 days of the start of the preparation.
(Case T-311/06, FMC Chemical SPRL v EFSA, para. 43)
Laval, para. 39)
v ECHA, para. 100)
Fees∞ Data Sharing Technical Equivalence
Validation of AS applications - rejection of application for non payment of fees within 30 days (Art 7.(2)) Mandatory where parties don’t agree (Art 63(3)) Decision on technical equivalence (Art 54.(4)) Renewal of AS applications - rejection of application for non payment of fees within 30 days (Art 13.(3)) Referral to unprotected data when technically equivalent (Art 64(1)) Rejection of application where further information requested for technical equivalence but not provided so rejected (Art 54.(5))▲ Validation of Union Authorisation - rejection of application for non payment of fees within 30 days (Art 43.(2)) Renewal of Union Authorisation - rejection of application for non payment of fees within 30 days (Art 45.(3)) Rejection of application for Technical Equivalence for non payment of fees within 30 days (Art 54.(3))
∞▲Same remedy for fees non-payments and /or failure to provide requested information under Reg. (EU) 613/2013, Reg. (EU) 564/2013 (also on SME status) and Reg. (EU) 354/2013.
PRODUCT AUTHORIZATION
RECOGNITION
IN PARALLEL
RECOGNITION
IN SEQUENCE
BIOCIDAL PRODUCTS
PRODUCT AUTHORIZATION MAXIMUM
APPROVAL PERIOD
(YEARS)
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
active (potential data waiver/adaptation)
characteristics in appropriate language(s)
To chosen evaluating CA (‘reference MS’):
product authorization, as appropriate
authorization sought To other MSs where national authorization sought:
MSs where national authorization sought
characteristics in MS required languages Translation of national authorization granted in reference MS into relevant official languages
active (potential data waiver/adaptation)
use across Union in appropriate language(s)
characteristics
(potential data waiver/adaptation)
simplified procedure in appropriate language(s)
APPLICATION
SUBMITTED TO Chosen CA where want to market product Application accepted on receipt of 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 Each CA of countries (other than reference MS) where want to market Application accepted if receives fee 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 ECHA, with confirmation of evaluating CA Application accepted if fee received within 30 days of informing applicant of fee
VALIDATION BY
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 Evaluating CA (‘reference MS’) within 30 days of its acceptance Applicant to provide missing information normally within max 90 days Each CA within 30 days of its acceptance Chosen CA within 30 days of ECHA acceptance subject to payment of CA fee Applicant to provide missing information normally within max 90 days 30 days for CA to validate thereafter No formal validation stage
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* Assumes that (i) each time period is used in full, (ii) periods for additional information are always required, (iii) that the Coordination Group, where
applicable, is able to resolve differences without requiring the Examination Procedure in Article 35, and (iv) that each stage follows on immediately from that preceding it.
PRODUCT AUTHORIZATION
RECOGNITION
IN PARALLEL
RECOGNITION
IN SEQUENCE
BIOCIDAL PRODUCTS
PRODUCT AUTHORIZATION EVALUATION BY
Chosen CA within 365 days of validation Applicant to provide missing information within normally max 180 days (during which 365 timer is suspended) 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
within 90 days of receipt of report and record agreement in Register for Biocidal Products Reference MS to enter report and summary and any conditions on marketing and use in Register 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
conditions not met Commission resolution procedure (including applicant) for mutual recognition derogation (public policy, public security, protection of environment, etc.) 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) ECHA submits draft summary within 30 days in all languages 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
APPROVAL/NON-
APPROVAL Chosen CA:
conclusions and reasons for granting or refusing authorization;
requesting comments within 30 days;
conclusions. 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 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 Commission authorization approval Regulation or non-approval decision
Commission can require conditions particular to certain MS territory or exclude a certain territory on MS derogation request Provided eligible, chosen CA must authorize within 90 days of acceptance of application or of submission of additional information requested by applicant
TIMELINE (DAYS)*
725 845 935 (If Coordination Group Required) 905 (725 + 180) 935 300
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non-biocidal uses, it will have to submit a registration for the quantities of the substance used in non-biocidal products.” (section 2.2.4.1)
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disrupting properties;
vPvB in accordance with Annex XIII to REACH
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* If the substanceis placed on the market before 1 Dec. 2010, then it is not required to be re- labelledand re-packaged under CLP until 1 Dec. 2012. ** If the mixtureis placed on the market before 1 June 2015, then it is not required to be re-labelledand re-packaged under CLP until 1 Jun. 2017. *** Labelling and packaging of DSP/DPD replaced (not as well as) Must classify, label and package in accordance withDirective 67/548/EEC & May classify, label and package under CLP*** Label and package
Classify under both Directive 67/548/EEC and CLP Must classify, label and package under CLP Must classify, label and package in accordance with Directive 99/45/EC** May classify, label and package under CLP *** Must classify, label and package under CLP
? Mixture ? Substance
REACH Entered into Force
1 June 2007
REACH Pre- Registration Deadline
1 Dec. 2008
1st REACH Registration
1 Dec. 2010
2nd REACH Registration
1 June 2013
3rd REACH Registration
1 June 2018
Directive 99/45/EC Repealed
1 June 2015
2008 2009 2010 2017 2018
CLP Entry into Force
20 Jan. 2009
Annex I of Directive 67/548/EEC Repealed
20 Jan. 2009 1 June 2015
2007
Directive 67/548/EEC Repealed
1 June 2015
2011 2012 2013 2014 2015 2016
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Procedure for establishing harmonized classification and labelling (CLH) Article 37 Regulation (EC) No. 1272/2008 (CLP)¹
Substances normally subject to CLH (Article 36 CLP) Proposal for inclusion may be submitted to ECHA: CLH dossier submitted to ECHA RAC forms an opinion on proposal Inclusion of CLH in Annex VI entry through ATP Regulation
Proposal and RAC opinion submitted to Commission ATP legal text drafted by DG GROW (ENTR) on the basis of RAC opinions of previous calendar year Commission inter‐service consultation REACH Committee
Regulatory procedure with scrutiny Possibility for submitting party to respond to public consultation Public consultation (45 days) Indicative timeframe of 3 to 9 months
KEY MSCA: Member State Competent Authority CLH: Harmonized classification and labelling ECHA: European Chemicals Agency RAC: Risk Assessment Committee of ECHA ATP: Adaptation to Technical Progress EP: European Parliament ¹ See also ECHA “Guidance on the preparation of dossiers for harmonized classification and labelling” (August 2014) ² Must be in format specified in second paragraph of Art. 37(2)
Respiratory sensitiser 1 CMR 1A; 1B or 2
Other substances if justified PPP or biocidal active substances By a MSCA where the product is made available on the market (Art. 37(1))
By a manufacturer, importer or downstream user of a substance in the absence of any previous CLH (Art. 37(2))
Note: if a manufacturer, importer, or downstream user submits a proposal for a substance not normally subject to CLH, it pays a fee to ECHA
Note: Dossier by MSCA only possibility for PPP or BP active substances
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Biocides Europe 2015 - 18th Annual European Conference Pre-Conference Workshop 24 November 2015
This presentation is indicative only and is not a substitute for comprehensive legal advice.
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REACH
(Art. 30 Phase-In Substances)
BPR
(Art. 63)
STANDARD (AND BURDEN) “Every effort” to ensure that the costs of sharing the information is determined in a “fair, transparent and non discriminatory way”
(burden on both parties)
“Every effort” to reach an agreement. Compensation determined in a “fair, transparent and non-discriminatory manner” OR parties may agree to submit matter to binding arbitration
(burden on both parties)
SUBJECT TO SHARING Study involving tests on vertebrate animals Tests or studies on vertebrates. Plus all tox., ecotox., env. fate and behaviour studies (for
PROCESS TRIGGERED BY SIEF participant Prospective applicant DECISION MAKER ECHA ECHA TIMELINES No earlier than 1 month after request of proof of costs No earlier than 1 month after name of data owner provided + 60 day maximum for ECHA decision
(Prospective applicant must have paid a share of costs before Decision)
SUB-LICENSING? No
(Legal entity specific unless otherwise agreed)
No
(Exception under Article 95 to an applicant for authorization in its supply chain)
COMPENSATION PRINCIPLES Costs shared equally Proportionate share of the cost COMPENSATION PROCEDURE (ABSENT AGREEMENT) Data owner may enforce € claim through MS Courts MS Courts decide on proportionate share REMEDIES AGAINST DECISION BoA + General Court BoA + General Court
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ACTIVE SUBSTANCE (AS) BIOCIDAL PRODUCT (BP) Approval of a NEW AS 15 years from the first day of the month following the date of adoption of AS approval decision (i.e. adoption of Implementing Regulation)
BP with a NEW AS 15 years from the first day of the month following the first decision taken to authorize a BP (either by a MS authority or by the Commission, Union authorization) Approval of an EXISTING AS 10 years from the first day of the month following the date of adoption of AS approval
If AS (product-type combination) is not already approved before Sept. 1, 2013, all data protection periods for AS (product-type combination) still under review remain until a (longstop of) December 31, 2025. BP with ONLY EXISTING AS 10 years from the first day of the month following the first decision taken to authorize a BP (either by a MS authority or by the Commission, Union authorization) RENEWAL/REVIEW of an AS approval 5 years from the first day of the month following the decision on renewal/review of a the approval of an AS RENEWAL/AMENDEMENT OF BP AUTHORIZATION 5 years from the first day of the month following the decision on the renewal/amendment of a BP authorization
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LoA or Forced Sharing
SS or PS "entitled to allow applicants to make reference". [Art. 95(4)]
Sub-licence to customer in own supply chain.
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Supporters of New AS or "third party" AS dossiers submitted along with a Product authorisation, will also be included in list
product consisting of, containing or generating that relevant substance "
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Free choice
supplier
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Tie between regulatory and commercial relationships!
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Commercial leverage remains
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https://circabc.europa.eu/d/a/workspace/SpacesStore/d0155521-069e-4e8c-91cc-
126006d32a83/Manual%20of%20decisions%20(obsolete%20as%20of%2001.10.2015
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Court (Third Chamber) of 1 March 2012 (reference for a preliminary ruling: Landgericht Hamburg – Germany - Söll GmbH v Tetra GmbH
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