Experiences with the simplified authorization procedure Christian - PowerPoint PPT Presentation

Experiences with the simplified authorization procedure Christian GUSTIN C-Tech Corporation Brussels, Nov 5, 2019 in collaboration with Arche and pIEt Consulting

Activation energy … (Arche + pIEt Consulting)

A complex supply chain — biocidal active substances (Annex I) — incorporated in a plastic carrier, called a ‘masterbatch’ — the masterbatch carrier is then mixed with a compatible thermoplastic material, which can be extruded into various end use applications Question: Which is the biocidal product ?

2 types of now BPR compliant end-use applications — Wire and cable, pipes and ducts — Films — = ‘treated articles’ (BPR) — treated articles can be biocidal products, if their primary function is biocidal

Objectives of the end-user s — keep harmful organisms away à protect their applications — without destroying/killing/harming these organisms à use of BPR PT 19 active substances, i.e. repellents

PT 19 ‘Repellents’ : 2 types — Repellent products : action at a distance of the product to be protected — Aversive products : action at the surface of the product to be protected

How to bring active substances into plastic articles ? — by using a ‘masterbatch’

What is a masterbatch ? — BPR definition (2015) : A masterbatch is a pre-dispersed (solid or liquid) concentrate of additive(s), such as pigments, anti-static, UV-blockers, flame retardants, antimicrobials (biocides)…, allowing the processor to proportion such additives accurately to a bulk product (for example natural polymer) during the manufacturing process. — Wikipedia definition : A masterbatch is a concentrated mixture of pigments and/or additives encapsulated during a heat process into a carrier resin which is then cooled and cut into a granular shape.

Masterbatch: is it a biocidal product ? — BPR definition of a biocidal product : (Art 3.a.1, first indent) « - 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 », …

Masterbatch: a biocidal product ? — a masterbatch is « a mixture » of active substance(s) and a polymer/carrier (solid mixture) — ‘in the form (granular shape, pellet form) it is supplied to the user’, it is however not used to destroy, deter, etc… à first indent of the definition does not quite match reality !

Masterbatch: a treated article ? — BPR (article 3.a.1, end): “ a treated article that has a primary biocidal function shall be considered a biocidal product” — but: a masterbatch does not have a primary biocidal function because its primary function is to bring substances into plastic. It is a carrier, primarily. — In fact, the true biocidal products in the supply chain are the active substances contained in the masterbatch. The masterbatch is the ‘container’, the ‘carrier’ of these biocidal products.

Mixture ? Treated Example article ? of an ink cartridge Or both ? Step 4: Mainly yes Guidance on requirements for substances in articles, June 2017 https://echa.europa.eu/documents/10162/23036412/articles_en.pdf

Decision tree (part 1) Note for guidance Treated articles CA-Sept14.Doc 6a

Does the treatment confer a primary biocidal function to the treated article ?

Decision tree (end) à it is a treated article, not a biocidal product

Masterbatch: a combination of — until 2015, according to ECHA definitions and Notes for Guidance, masterbatches could be considered as a combination of an article and a substance/mixture — and as such they were considered as treated articles and did not require authorization to place on the market

2015: masterbatches = biocidal products — in september 2015 à new Note for Guidance The purpose of this note is to clarify the position of masterbatches in the context of Regulation (EU) No 528/2012 (the BPR) and to propose a way forward in order to decrease uncertainty — new definition of ‘biocidal function’: ‘conferring a biocidal property to an article is a biocidal function’

Note for Guidance on masterbatches: — ‘ conferring a biocidal property to an article is a biocidal function’ (?) and: — ‘A masterbatch should be regarded as a biocidal product if it is has a biocidal function in the form in which it is supplied to the user’ à BPR authorization required à immediately, without any transition period ! L à what can we do ?

Simplified procedure - timetable — for aversive masterbatches based on Annex I a/s à simplified procedure available — in principle, an authorization is achievable in 3 months — but: the masterbatch concept was fairly new for the biocidal products industry and for the eCA… more time needed ! — in the meantime, commercialization had to be stopped L

Simplified procedure — Should not include risk assessments, as the active substances are already listed in Annex I — Should be limited to efficacy and storage stability assessments — Issue with sensitization: some Annex I listed oils are sensitizers : are further tests needed ?

Efficacy assessment — The first Dossier submitted in the Netherlands (ctgb) required extra time due to efficacy testing issues : — applications not really known/understood — efficacy of PT 19 aversive products not as easy to assess as bio-cidal products (PT 14 and PT 18) — a lack of available standard testing methods (W&C) — tests results from several labs with different test methods or protocols — test methods/protocols not really familiar to examiners — expensive field tests !!!

Other issues — Dosage of masterbatch in articles: successful test results were achieved with a range of % dosage (e.g. with 2,5%,2,8%, 3%) à need to submit a single value to be specified (in such case the highest % in the tested samples, i.e. 3%) — Storage stability on masterbatch – redo all tests ? — Team of examiners changed after a few months : need to re-explain many topics — Different view on the tests evaluations by the eCA

Other issues: which applicant ? — C-Tech Corporation : Mumbai, India — C-Tech not based in the EU à EU based company required as applicant — Current distributors/partners submitted dossier — Authorization granted to them

Authorizations — First authorization gained in May 2018 (dossier introduced in 2016) — Second dossier (films) introduced in 2019 — Ctgb overbooked à eCA in Lithuania — Good coordination with Ctgb — Lessons learnt ! — à Second authorization(films) in September 2019

Conclusions — the simplified procedure is not such a straighforward process — efficacy assesment is the main hurdle for PT19 applications — close collaboration with consultants and eCA is key — persistency is required and then … it eventually works!

Thank you for your attention !