Where we are on biocides
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- Augustine Dorsey
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1 Where we are on biocides Biocides Day 24 October 2018 Erik van de Plassche Chair, Biocidal Products Committee European Chemicals Agency
2 Biocides characteristics Very complex High workload Limited capacity / resources Limited political visibility Small is beautiful freedom
3 Luuk van Middelaar in The Passage to Europe: Thus far, the European Union has been able to muddle through on a middle ground that keeps the multitude of nations integrated, though still independent. European Union, 2012 / Source: EC Audiovisual Service / Photo: Frederic Sierakowski
4 Five years of operation: 2013 to 2018 IT: R4BP, IUCLID, SPC Editor, EUSES Guidance: volumes I to IV Transition periods over First Union authorisations Appeals, court case and Ombudsman case
5 Data sharing: disputes and inquiries inquiries disputes
6 Data sharing: disputes and appeals disputes submitted closed permission to refer granted yes no withdrawn appeals
7 List of active substances and suppliers (Article 95) Complete dossier Letter of access Mixed application
8 Technical equivalence applications Tier I Tier II TE not TE
9 Review Programme: 39% finalised % I (PT 8; 14; 16; 18; 19; 21) II (PT 3; 4; 5) III (PT 1; 2) IV (PT 6; 13) V (PT 7; 9; 10) VI (PT 11; 12; 15; 17; 20; priority lists with 22) product-types
10 Speeding up the Review Programme Commission Biocidal Products Committee
11 Approval of active substances Approved: 255 active substance and producttype combinations (144 active substances, of which 6 micro-organisms) Non-approval decisions based on evaluation and peer review: 15 active substance and product-type combinations Of all active substances for which an opinion adopted by Biocidal Products Committee: 19% meet the exclusion criteria and 12% are candidates for substitution
12 Review Programme workload: 377 I: Dec 2015 II: Dec 2016 III: Dec 2018 IV: Dec 2019 V: Dec 2020 VI: Dec Total
13 Renewal of active substance approvals: 5 active substance/product-type combinations not supported 16 Expected Received Finalised
14 Impact of endocrine disruptor criteria From now on, no Commission decision without an assessment against the new ED criteria (except for non-approval proposals) Commission approval decisions on hold for 11 active substances for 33 active substance and product-type combinations, due to ED assessment Two evaluations received by ECHA from Member State authorities since August 2017 Co-formulants for product authorisation
15 Approval of in situ active substances Additions to the Review Programme: 55 active substance and product-type combinations for 28 active substances (Article 93 and 94; redefinitions) Majority for in situ generated active substances Do we make it too complex?
16 New actives substances Biocidal Products Directive: 3 active substances for 13 active substance and producttype combinations under evaluation by authorities Biocidal Products Regulation: limited number of applications almost no new chemistries
17 Product authorisation National authorisations: granted for biocidal products (families) Union authorisations: granted for 2 biocidal product families and 2 for the same biocidal product family Simplified authorisation: 82 biocidal product authorisations granted Renewals for rodenticides and wood preservatives National regimes for product authorisation
18 National authorisations by product-type
19 Coordination Group: referrals Informal Formal
20 Referrals by product-type other
21 Referrals: success Total 124 Consensus: product can be authorised 112 Consensus: product cannot be authorised 0 Referral withdrawn 2 Disagreement referred to Commission 7 Disagreement referred by Commission to BPC 2 Under discussion 3
22 National authorisation: changes administrative minor major clas
23 Union authorisation ECHA acceptance Status of applications submitted in: Total Validation Evaluation Peer review BPC opinion COM decision
24 Same biocidal products for Union authorisation ECHA acceptance Status of application submitted in: total Validation Evaluation ECHA opinion COM decision 2 2
25 Access to documents requests: 7 active substance related 2 product related 1 for meeting documents requests: 7 active substance related 2 product related requests: 11 active substance related 4 product related 2 for meeting documents 1 for internal procedures (Article 95 list) requests: 4 active substance related 46 product related: 35 documents available and disclosed, 33 product assessment reports and 2 SPCs
26 Conclusions Review Programme did speed up but we have to keep the momentum Union authorisation: prevent formation backlog MSCAs need to focus on the Review Programme this will free up resources used in national regimes Need to reduce complexity in-situ, ED and SPC
27 Thank you Follow our news News: echa.europa.eu/subscribe Twitter: EU_ECHA Facebook: EUECHA YouTube: Euchemicals LinkedIn: European Chemicals Agency
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