eu regulation on the making available and use of biocidal...
TRANSCRIPT
M. Ludovic Chatelin
European Commission
EU Regulation on the
making available and use
of biocidal products
(BPR)
Workshop on antifoulings
SeaEurope
23/09/2016
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I – Objectives and main provisions of the legislation
II – State of play for antifoulings in EU
III – Short term key dates with regulatory consequences
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I – Objectives and main provisions of the legislation
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Biocidal Product Regulation (BPR)
Regulation (EU) No 528/2012 of 22th May 2012, replaces Directive 98/8/EC
BPR entered into application on 1st September 2013
Main objectives :
Improve the harmonisation of the internal market while ensuring a higher level of safety for health and environment
Encourage innovation and the making available on the market of products with better profiles
Establish provisions to partly regulate treated articles with biocides
Establish more detailed procedures for the making available on the market of biocidal products, in order to ensure a better enforcement by economic operators and authorities
22 different Biocidal Product-types : Antifouling products = PT 21
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Biocidal Product Regulation (BPR)
Keystones :
o Approval of active substances (AS) at EU level
o Authorisation of biocidal products containing these AS at national level or EU level
A lot of provisions are now applicable :
o Use of the various procedures for new applications
AS approval procedures
National authorisation / mutual recognition procedures at Member State level
Possibilities of Union authorisation (not for antifouling products)
Possibilities for parallel trade (art 53)
Applications to European Chemicals Agency (ECHA) for technical equivalence of
sources of AS (art. 53)
Applications to ECHA for registration on the AS suppliers list (art. 95)
Etc.
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Application of the BPR
New principles in force :
Exclusion (Art 5 - CMR, PBT/vPvB, POP, ED)
Substitution of active substances (Art 10)
Comparative assessment of biocidal products (Art 23 – BP contain AS meeting the
substitution criteria)
Nanomaterials excluded if not explicitly covered in the approvals of AS
Labelling provisions of treated articles (art.58)
Mandatory data sharing of data on vertebrates (art. 62)
Mandatory data sharing of all toxicological and environmental data for the sake of
the listing on the AS supplier list of ECHA (art. 95)
Data protection periods (Art. 60)
Etc.
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Obligations
For all parties involved : Industry, Member States, Commission, ECHA
For Industry:
Compliance with "basic" provisions of the BPR (ex: AS in the review programme, transitional
measures/systems in Member States, BPR authorisation when needed, use compliant products etc.)
Compliance with the procedures (timing for submitting application, additional data , fee payments etc…)
Compliance with the sources of active substances contained in BPs, list of suppliers of AS (art. 95)
Provisions on R&D (art. 56)
Compliance with treatment or incorporation of AS supported in EU in Treated Articles (art. 58 + transitional
measures 94)
Compliance with labelling of Treated Articles when needed (art. 58, no transitional measures)
Authorisation holder :
Classification & Labelling (art. 69)
Information of any adverse effect (art. 47)
Holding a register during the validity of the authorisation + 10 years after the end of validity (art. 68)
Quality compliance for manufacturers (art. 65)
Notification for poisoning surveillance (art. 73), etc.
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II – State of play for antifoulings in EU
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Organisation of the biocides framework
Objective : finish the review programme by the end of 2024
240 existing active substances (ie. present before 14th May 2000 on EU market)
supported for one or several product-types = around 620 dossiers
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Process of AS evaluation
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Once the applicant has submitted its dossier :
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Minimum 50 opinions and decisions per year
Priorities in the Review Programme Regulation (EU) No 1062/2014
depending of PTs (cf. Annex III) :
Dates = Deadlines
Management of Review programme
Product-typesTime limits for MS to submit the
assessment report to ECHA
Time limits for ECHA (BPC) to
start the preparation of the
opinion
8, 14, 16, 18, 19 and 21 31.12.2015 31.3.2016
3, 4 and 5 31.12.2016 31.3.2017
1 and 2 31.12.2018 31.3.2019
6 and 13 31.12.2019 31.3.2020
7, 9 and10 31.12.2020 31.3.2021
11, 12, 15, 17, 20 and 22 31.12.2022 30.9.2023
Antifoulings
Specific case of antifoulings
Discussions in 2013-2014 with Member
States and EU stakeholders on the
management of antifoulings
Endorsed approach:
CA-March14-Doc.4.2- Final - Approach for
antifoulings PT21.doc
https://circabc.europa.eu/w/browse/7a8cd478-2790-
45be-8f88-e1870bced8a5
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Concerns : from evaluation of AS, unacceptable risks sometimes shown to one or more environmental compartments (ex: harbour/marina), and sometimes risks for human health, for different one or several stage of use (application, maintenance & repair, in service), etc.
Nevertheless, benefits : prevent the growth of marine life on ships and boats allowing their safe and efficient operation, contribution to prevention of spreading of invasive alien species, reduction of fuel consumption and related greenhouse gases emissions
Decision making for the approval of AS :
Without prejudice to exclusion / substitution criteria of the BPR, and as long as one safe use is demonstrated, it was agreed :
To approve active substances for PT21 on the basis on the same generic conditions. Additional specific conditions or restrictions can be added on a case-by-case basis
To establish the same expiry date of approval for existing AS, to facilitate the comparison at the renewal stage : 31/12/2025.
To flag specific concerns related to each individual active substance in the assessment report and EHA opinions, to help BP authorisation and the renewal stage.
Issues
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The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
In the event that products are subsequently authorised for use in non-professional antifouling products, persons making products available on the market for non-professional users shall ensure that the products are supplied with appropriate gloves.
Authorisations are subject to the following conditions:
1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.
2) Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry.
3) Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area, on impermeable hard standing with bunding or on soil covered with an impermeable material to prevent losses and minimise emissions to the environment, and that any losses or waste shall be collected for reuse or disposal.
4) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded
Generic conditions
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Authorisation of products
As far as possible, harmonisation of authorisation across EU, in particular for use on large commercial boats or superyatch >25m and risks for the environment,
These vessels are expected to travel across EU
Member States can also, on dully justified grounds, derogate to the mutual recognition and decide to ban or restrict the use of antifouling products at local levels , in accordance with Article 37 of the BPR.
For instance, instance ban the use in sensitive areas, specific marinas, specific coastal zones, natural reserve, Natura 2000 zones etc.
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Progress on active substances for PT21
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Review of existing active substances (existing BP can stay on the market under transitional national rules of each Member State until their review finalised)
New active substances (BPs cannot be placed on the market until authorised)
( Medetomidine : substance under substitution, as being Persistent and Toxic )
Active substance EC No CAS No StatusReference for the decision
on approval/non-approvalDate of approval
Zineb 235-180-1 12122-67-7 Approved Regulation (EU) No 92/2014 01/01/2016
DCOIT 264-843-8 64359-81-5 Approved Regulation (EU) No 437/2014 01/01/2016
Tolylfluanid 211-986-9 731-27-1 Approved Regulation (EU) 2015/419 01/07/2016
Copper pyrithione 238-984-0 14915-37-8 Approved Regulation (EU) 2015/984 01/10/2016
Cybutryne 248-872-3 28159-98-0 Not Approved Decision (EU) 2016/107 x
Copper flakes 231-159-6 7440-50-8 Approved Regulation (EU) 2016/1088 01/01/2018
Dicopper oxide 215-270-7 1317-39-1 Approved Regulation (EU) 2016/1089 01/01/2018
Copper thiocyanate 214-183-1 1111-67-7 Approved Regulation (EU) 2016/1090 01/01/2018
Dichlofluanid 214-118-7 1085-98-9 Still under assessment x x
Pyrithione zinc 236-671-3 13463-41-7 Still under assessment x x
Active substance EC No CAS No StatusReference for the decision
on approval/non-approvalDate of approval
Tralopyril NA 122454-29-9 Approved Regulation (EU) No 1091/2014 01/01/2016
Medetomidine NA 86347-14-0 Approved Regulation (EU) 2015/1731 01/01/2016
At technical level in ECHA
Revision of the guidance document on the environmental exposure assessment for harbour/marina for pleasure crafts, to help to perform the risk assessment on antifouling products
Involvement of the industry stakeholders (ex: CEFIC, CEPE..)
Finalisation by the end of the year
Guidance documents are used by prospective applicants for product authorisation
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IV – Short term key dates with regulatory consequences
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Deadlines on products and treated articles
1st semester 2017 :
Art 89 of BPR : Ban of antifouling paints containing cybutryne
Consequence on antifoulings paints : ban of supply on 27/01/2017, ban of use
on 27/07/2017
Consequence on treated articles (ex: treated fishing nets with cybutryne ) : not
possible to place on the EU market anymore (1st supply; what is already in the EU
supply chain can continue to be supplied); the use of treated articles is still possible
Art 94 of BPR : No possibilities to place on the market treated articles with active
substances not under evaluation in the EU (ex: importation of treated fishing nets
etc.) on 1st March 2017
1st supply on the EU market impossible (ex: importation) ; what is already
in the EU supply chain can continue to be supplied
The use of those treated articles is still possible
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Product authorisations
On 01/01/2018 : As most BP contains copper compounds, deadline for submission
for product authorisation for many antifouling paints which contains approved active
substance
Application for product authorisation must be submitted in Member States,
possibility to request mutual recognition.
If no application for product authorisation is submitted in due time, products will
not be allowed to be made available on the market anymore, and not used anymore
(cf. Article 89 BPR)
NEED TO FOLLOW CLOSEDLY THE REVIEW PROGRAMME OF ACTIVE
SUBSTANCES, ANTICIPATION BY PAINT MANUFACTURERS, COMMUNICATION IN
THE SUPPLY CHAIN TO USERS
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01/01/2016 1/01/2019 31/12/2025
1st
substance
being
formally
approved :
Zineb
Expiry date of
approval for all
existing AS for
PT21*
Estimated
date of
approval of
the last AS for
PT21
10 y*
31/06/2024
Deadline for
submission
for
application
for renewal
of approval
of AS*
550d
If the approval is
not extended /
renewed :
authorisation of
BPs will be
cancelled (ie. AS
not approved
anymore)
Today
* Provided AS is not
subject to
exclusion/substitution
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Timeline for Active substances
approvals
1/01/2019 31/12/2020 31/12/2025
Expiry date of
approval for all
existing AS for
PT21*
Estimated date
of approval of
the last AS for
PT21
=
Date by which
all applications
for product
authorisation
or existing BPs
have been
submitted
Estimated
date of
authorisation
of the existing
BPs for PT21
31/12/2030
Expiry date
authorisation for
existing BPs **
31/06/2029
Deadline for
submission
for
application
for renewal of
authorisation
for existing
BPs
550d 3,5y
If the approval is
not extended /
renewed :
authorisation of
BPs will be
cancelled (ie. AS
not approved
anymore)
Authorisations granted for 10 y**
Today
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** Provided BP is not
subject to a
comparative
assessment
Date of approval
of most Copper
compounds
=
Submission of
many
applications for
antifouling BP
authorisation
(most BP contain
copper
compounds)
1/01/2018
Timeline for Biocidal product
authorisations
* Provided AS is not
subject to
exclusion/substitution
Conclusion
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BPR : continuity with the former legislation (1998), new principles
Various challenges for IND, Authorities
Coming years for antifoulings :
Only products containing sources of active substances listed on
ECHA Article 95 list can remain on the market since 1st
September 2015
Finalisation of the review of antifouling active substances by 2017
Authorisations of antifouling products by 2020
Work on alternatives by IND ?
Fulfil objectives of the legislation : harmonisation of EU market,
ensure better protection of human health, animal health and
environment
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Thank you for your attention
For further information :
Commission website :
http://ec.europa.eu/health/biocides/policy/index_en.htm
https://circabc.europa.eu/w/browse/e947a950-8032-4df9-a3f0-f61eefd3d81b
ECHA website & Helpdesks on Biocides :
http://echa.europa.eu/regulations/biocidal-products-regulation
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