2011 11-17-smart coating workshop - antibacterieel - het gebruik van biociden in textiel - centexbel
Europese ontwikkelingen op het gebied van biociden · Europese ontwikkelingen op het gebied van...
Transcript of Europese ontwikkelingen op het gebied van biociden · Europese ontwikkelingen op het gebied van...
Mario Nagtzaam EC, DG SANTE, Unit E4 Pesticides and Biocides
Europese ontwikkelingen op het gebied van biociden
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Ctgb relatiedag, 13 juni 2019, EDE
Agenda 1. Wat gaat er niet gebeuren?
2. Wat komt er?
i. Europese Hof
ii. Meer transparantie
iii. Actieve stoffen
iv. Producten
v. EDs
vi. Controles
vii. 2021 rapport
viii.Niet technische ontwikkelingen
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Rustpauze
Herziening regelgeving (korte termijn)
Wat gaat er niet gebeuren?
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Agenda 1. Wat gaat er niet gebeuren?
2. Wat komt er?
i. Europese Hof
ii. Meer transparantie
iii. Actieve stoffen
iv. Producten
v. EDs
vi. Controles
vii. 2021 rapport
viii.Niet technische ontwikkelingen
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Court cases -Court caseCourt cases T337/18, T347/18, T
T337/18 Laboratoire Pareva PHMB
T734/18 Sumitomo empenthrin
C-592/18 pre-judiciële vragen
Board of Appeal -ECHA
Wat gaat er gebeuren
Hof van Justitie van de Europese Unie
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Court cases -Court caseCourt cases T337/18, T347/18, T
Permanent Comité
ATDs
Dissemination
General Food Law
Aarhus
Wat gaat er gebeuren?
Meer transparantie
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Court cases -Court caseCourt cases T337/18, T347/18, T
Wat gaat er gebeuren?
Actieve stoffen
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Review Programme - state of play
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Review Programme – state of play
Delays in the review programme
Discussions in 2017-2018 with Member States and stakeholders representatives, agreements on some actions :
CA-March18-Doc.5.1a - Final - Actions for AS review programme.pdf
ECHA workshop on the review programme on 12-13 February 2019 : further actions under consideration, upcoming discussions in CA meetings
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Court cases -Court caseCourt cases T337/18, T347/18, T
Versnelling werkprogramma
Meer besluiten
Innovatie
Wat gaat er gebeuren?
Actieve stoffen
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Agenda 1. Wat gaat er niet gebeuren?
2. Wat komt er?
i. Europese Hof
ii. Meer transparantie
iii. Actieve stoffen
iv. Producten
v. EDs
vi. Controles
vii. 2021 rapport
viii.Niet technische ontwikkelingen
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Court cases -Court caseCourt cases T337/18, T347/18, T
Wat gaat er gebeuren?
Producten
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Court cases -Court caseCourt cases T337/18, T347/18, T
Meer toelatingen
Meer toelatingen van de unie
Meer doorverwijzingen van bezwaren aan de EC?
Wat gaat er gebeuren?
Producten
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First Union authorisations granted in 2018: 7 Union authorisations for BPFs >> 48 products authorised for the entire EU market
Product authorisation
National authorisation and amendments
3306
Mutual recognition in parallel
1447
Mutual recognition in sequence
3959
Simplified authorisation 149
Total 8861
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Number of products authorised under BPR
Union authorisation
14 26
94
150
8130
1440
134
284
365395
0
50
100
150
200
250
300
350
400
450
2013 2014 2015 2016 2017 2018 2019 2020
UA applications for single products, families and cumulative number of applications
UA totalapplications
UA cumulativeapplications
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Number of referrals submitted to CG
Product authorisations – harmonisation between MSs
Total number of referrals submitted to CG: 154
Number of referrals per product-type
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Referrals – agreement rate, disagreements referred to Commission
Product authorisations – harmonisation between MSs
Number % Referrals 154 Consensus agreement. Product can be authorised through Article 19 or Article 26 136 88.3 Consensus agreement. Product cannot be authorised through Article 19 or Article 26 0 0 Referral withdrawn 3 1.9 No agreement reached. Disagreement referred to Commission 8 5.2 Referrals under discussion 7 4.5
• high agreement rate (88.3%) • 5.2% of referrals resulted in disagreement referred to COM
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Standing Committee
BPC
CA meeting
Coordination Group
BPR Subgroup Forum
Court cases -Court caseCourt cases T337/18, T347/18, T
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BPR
IAs and DAs
EC notice
CA guidance
Technical guidance (ECHA)
CG document
s
ECJ rulings BoA
Example of referral timeline
Applicant submitted an application for the mutual recognition of BPF containing the active substance deltamethrin
On 23 February 2017 Germany referred an objection to the CG On 14 March 2017 and 10 May 2017 referral was discussed in CG On 18 May 2017 the unresolved objection referred to the EC On 30 May 2018 the Standing Committee gave a favourable opinion On 28 September 2018 published the Commission Implementing
Decision (EU) 2018/1305 in Official Journal
Product authorisations – harmonisation between MSs
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Emergency authorisations
Emergency authorisations notifications per year
Emergency authorisations notifications per Member State and COM decisions on extensions
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Agenda 1. Wat gaat er niet gebeuren?
2. Wat komt er?
i. Europese Hof
ii. Meer transparantie
iii. Actieve stoffen
iv. Producten
v. EDs
vi. Controles
vii. 2021 rapport
viii.Niet technische ontwikkelingen
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Court cases -Court caseCourt cases T337/18, T347/18, T
In situ
BPFs
DBPs
MRLs
Bestuivers
UFI
Wat gaat er gebeuren?
Producten
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Court cases -Court caseCourt cases T337/18, T347/18, T
-CA-guidance in situ biocidal products July CA meeting
-In situ nitrogen for the preservation of museum objects
Article 55(3) Essentieel voor bescherming van cultureel erfgoed
Wat gaat er gebeuren?
Producten In situ
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Court cases -Court caseCourt cases T337/18, T347/18, T
In situ
BPFs
DBPs
MRLs
Bestuivers
UFI
Wat gaat er gebeuren?
Producten
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Timelines By when should the UFI be on the label?
Application of Unique Formula Identifier for biocidal products
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UFI: unambiguous link between a product placed on the market and the information on the specific mixture
rapid and precise identification of the chemical formulation of the product in case of emergencies
Consumer uses Industrial uses only Step-wise application 1 January
2020
1 January 2021
1 January 2024
1 January 2025
Agenda 1. Wat gaat er niet gebeuren?
2. Wat komt er?
i. Europese Hof
ii. Meer transparantie
iii. Actieve stoffen
iv. Producten
v. EDs
vi. Controles
vii. 2021 rapport
viii.Niet technische ontwikkelingen
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Endocrine disruptors
Status: Discussions ongoing with CAs for the update of Annexes II and III to BPR >> expert meeting; draft delegated act to be presented at CA meeting in Sept 2019
RP and renewals
Draft CG-document on non-active substances
Early review of three active substances (iodine, PVP iodine, zineb): process still to be triggered by COM. Probable timing: 2nd half of 2019
COM triggers early review
consultation– opportunity to submit
comments COM asks ECHA to provide an opinion
ECHA submits its opinion within 270
days
COM adopts the act
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Amendments of Annex II and III to BPR – under discussion in CA meeting. Main drivers for amendments:
ED criteria : Entry into force of scientific criteria for assessing the endocrine disrupting potential of substances
Need to adapt information requirements to technical and scientific progress Reduction of animal testing Better protection of human and animal health Improvement of consistency of BPR Annexes Streamlining of certain requirements for micro-organisms
Update of information requirements of the BPR
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Agenda 1. Wat gaat er niet gebeuren?
2. Wat komt er?
i. Europese Hof
ii. Actieve stoffen
iii. Producten
iv. EDs
v. Controles
vi. 2021 rapport
vii. Niet technische ontwikkelingen
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FORUM-BPRS –treated articles
Controls - to ensure a level playing field on the market
Controls
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Fact finding missions in 5 MSs, conducted between November 2017 and June 2018 (HU, DE, ES, BE, NL); workshop next week (19-20 June)
Overview report –
publication in April/May
Workshop with Competent Authorities in June 2019
(Grange) – discussion of main findings
Follow-up actions???
Agenda 1. Wat gaat er niet gebeuren?
2. Wat komt er?
i. Europese Hof
ii. Actieve stoffen
iii. Producten
iv. EDs
v. Controles
vi. 2021 rapport
vii. Niet technische ontwikkelingen
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Article 65(3) reporting - background
Art. 65(3) >> Member States to report every five years on the implementation of the BPR – Year 2020
Art. 65(4) >> COM to produce a composite report to the Council and European Parliament, based on MSs reports – Year 2021
Agenda 1. Wat gaat er niet gebeuren?
2. Wat komt er?
i. Europese Hof
ii. Actieve stoffen
iii. Producten
iv. EDs
v. Controles
vi. 2021 rapport
vii. Niet technische ontwikkelingen
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Brexit New EP New Commission
Non-technical developments
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