1 Il nuovo regolamento : prospettive e novità dalla Commissione Europea MARISTELLA RUBBIANI C S C - ISS ROMA
2 Why a new Regulation. -The influences of the REACH Regulation (setting common data on vertebrates) -The influences of the new regulation on plant protection products (Cut-off criteria) -The influences of the new directive on the sustainable use of plant protection products (comparative assessment) -The state of the art and delays in the review process
3 From Directive to Regulation Change of legal form The Directive has been turned into a Regulation. As a result, there will be no need for national transposition measures, which is also expected to ensure more harmonised implementation of the regulatory framework in the Member States.
4 New regulation
5 BPR 97 Articles 6 Annexes Application starting from 1 September 2013
6 Definition of common deadlines: Receivements of application for authorization Removal from the market of not authorized products Definition of harmonized guidelines Granting of authorizations/mr
9 'biocidal products' means [ ] substances, mixtures or articles in the form in which they are supplied to the user, consisting of, containing or generating one or more active substances, [ ] with the primary 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 [ ];
10 'making available on the market' means any supply of a biocidal product or of a treated article for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
11 'national authorisation' means an administrative act by which the competent authority of a Member State authorises the placing on the market and the use of a biocidal product in its territory or in a part thereof; union authorisation means an administrative act by which the Commission authorises the placing on the market and the use of a biocidal product in the territory of the Union or in a part thereof;
12 'technical equivalence' means similarity as regards the chemical composition and hazard profile of a substance produced from a different manufacturing source, compared to the substance of the reference source with respect to which the initial risk assessment was carried out;
13 'frame formulation' means a group of biocidal products having similar uses and presenting specified variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications and where such [ ] variations do not adversely affect the level of risk or the efficacy of these products;
14 'letter of access' means an original document, signed by the data owner or its representative, which states that the data may be used by the competent authorities, the European Chemicals Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation;
15 Listing of active substance in Annex I requires specification of: (a) (b) the minimum degree of purity of the active substance; the nature and maximum content of certain impurities; (c) the product-type as outlined in Annex V; (d) (e) manner and area of use; designation of categories of users; (f) other particular conditions based on the evaluation of the information related to that active substance.
16 Competent authority: That competent authority shall be responsible for the evaluation of the application. 2. The Agency shall [ ] notify the evaluating competent authority without delay that the application is available in the Agency database. 3. Within 60 days of receipt of an application, the Agency shall validate the application if it complies with the following requirements (completeness check): (a) the data required in accordance with points (a) and (b) of Article 6(1) have been submitted; (b) it is accompanied by the fees payable under Article 70. The validation shall [ ] include a check that all the required data or justifications for the adaptation of data requirements have been submitted, but not an assessment of the quality or the adequacy of that data or such justifications [ ].
17 Elementi innovativi a) Iscrizione dei biocidi (principi attivi) in un unico allegato b) Un biocida classificato CMR in categoria 1A o 1B ai sensi del regolamento (CE) n.1272/2008 o identificato come interferente endocrino può essere iscritto nell allegato I solo se: l esposizione è trascurabile (è utilizzato in sistemi chiusi ) oppure è necessario per contrastare un pericolo grave per la salute pubblica oppure non esistono sostanze o tecnologie alternative che possano contenere organismi nocivi di rilevante impatto per la salute umana e per l ambiente
18 Elementi innovativi c) Sono riorganizzati gli allegati (allegato II e III ) relativi ai dati richiesti per la valutazione dei biocidi (studi tossicologici, studi ecotossicologici /ambientali e studi sulle proprietà fisico-chimiche) d) Sono fornite indicazioni in un allegato specifico (allegato IV) relativamente ai dati che possono essere omessi oppure sostituiti con dati predittivi (Q) SAR o con dati ottenuti con metodi in vitro e) Le domande di iscrizione di un principio attivo sono presentate all Agenzia europea per le sostanze chimiche (ECHA) e allo Stato membro scelto per la valutazione degli studi forniti
19 Cut/off criteria/sostanze attive candidate alla sostituzione f) Sono definiti principi attivi destinati alla sostituzione o potenzialmente sostituibili le sostanze che: presentano un ADI o un RDF o un AOEL significativamente inferiore a quello di altri p.a. iscritti in allegato I per lo stesso tipo di uso presentano almeno due caratteristiche P B T (secondo i criteri indicati dall allegato XIII del regolamento REACH) suscitano preoccupazioni in merito a effetti neurotossici o immunotossici sono classificate come CMR in categoria IA o IB sono identificate come interferenti endocrini (IE)
20 Rinnovo delle iscrizioni dei principi attivi nell allegato I g) La prima iscrizione di un principio attivo nell allegato I ha una durata massima di 10 anni ma il rinnovo dell iscrizione può essere a tempo indeterminato (salvo per i p.a. sostituibili = durata determinata) h) Per l iscrizione di un p.a. nell allegato I è previsto il pagamento di una tariffa a copertura dei costi dell Agenzia europea i) l autorizzazione di un prodotto (formulato contenente il p.a.) può essere rilasciata per una formulazione unica o per una formulazione quadro (periodo max 10 anni) l) la formulazione quadro può comprendere prodotti che presentano variazioni limitate di tutti i componenti, tali da non incidere sul livello di rischio
21 Biocidi a basso rischio m) Sono definiti biocidi a basso rischio i prodotti che soddisfano entrambe le seguenti condizioni: Rapporto tra concentrazione ambientale prevista (PEC) e concentrazione prevista priva di effetti (PNEC) < 0,1 Rapporto tra dose senza effetto osservato (NOAEL) ed esposizione prevista > 1000 I biocidi a basso rischio devono dare luogo ad una esposizione trascurabile Non sono comunque considerati a basso rischio i prodotti che soddisfano una delle seguenti condizioni: rispondono ad almeno uno dei 3 criteri P B T contengono un p.a. identificato come IE o immunotossico o oneurotossico o C M R
22 Riconoscimento reciproco delle autorizzazioni n) la domanda di riconoscimento di un autorizzazione concessa da un altro Stato membro viene esaminata entro 4 mesi o) può essere presentata da un ente pubblico, da un ente scientifico che si occupa del controllo dei parassiti o da un organizzazione professionale, con il consenso del titolare dell autorizzazione p) può essere presentata una domanda per più autorizzazioni nazionali trasmettendo il fascicolo ad una sola autorità di riferimento q) deroghe al riconoscimento reciproco delle autorizzazioni per avicidi, pescicidi e prodotti per il controllo dei vertebrati
23 Autorizzazioni comunitarie di biocidi, commercio parallelo, protezione dei dati e articoli e materiali che contengono biocidi Sono previste autorizzazioni rilasciate dalla Commissione Europea per: biocidi che contengono p.a. nuovi biocidi a basso rischio L autorizzazione comunitaria è valida in tutti gli Stati membri Viene introdotta la licenza di commercio parallelo (art.44) Vengono stabiliti nuovi periodi di protezione dei dati per i principi attivi iscritti nell allegato I e per i biocidi (art.49) Possono essere immessi sul mercato (al più tardi a partire dal 2017) solo articoli e materiali che contengono biocidi autorizzati o in corso di valutazione (art.81) Viene stabilito il criterio dell assessment comparativo per i prodotti
24 Some specific issues Simplifications Authorization procedures Timing Fees SMEs Data sharing Free rider Treated Articles Frame formulation vs. biocidal product family Products containing non-eu evaluated AS source Technical equivalence Sustainable use Low risk Central Agency (ECHA) role
25 Simplification of product authorisation The current system is a national based authorisation system to which the mutual recognition principle apply. The system poses a problem in so far as there is a lack of adequate resources at the national level to handle the great number of biocidal substances and products that need to be authorized or re-authorized.
26 Simplification of product authorisation The authorities propose to simplify the mutual recognition and conflict resolution mechanisms notably by allowing MS to initiate mutual recognition. In addition, it is proposed to set up a single community authorisation system according to which: After being authorized in one MS, products could be placed on the market of other MS with no need to additional administrative procedures other than complying with labelling rules Include a safeguard clause allowing MS to refuse a product in certain pre-defined circumstances Set up a dispute resolution mechanism
27 Union Authorisation (UA) Could apply to a product from any PT with provison of similar use but with some limitations Can apply immediately Many of the products concerned are widely considered to present little or no risk since they were not subject to national regulations pre-bpd.
28 Timing as currently presented in BPR: UA timeline = 605 days National authorisation = 425 days Parallel application = 515 days**** (authorisation + MR applications at the same time) MR alone = 180 days **** Timeline assumes that first authorisation cannot be granted until all MS have agreed on MR and does not include time for validation, nominally 90 days (total timeline = 605 days
29 Harmonized fees The current system is a national-based fee system where the fees may vary from one Member State to the other from to for the evaluation of an active substance and from 1000 to for product authorisation. In addition, since the fees apply to each PT, up to 1 million Euros can be paid for a substance in 13 PTs. The authorities wish to harmonise and centralize the fee system as well as set up reduced fees for small and medium-size enterprises (SMEs.)
30 Member States fees Product Authorisation fees are expected in the range 15 20k depending upon the Evaluating Member State. Mutual recognition fees are in the range 1 5k. Plus all the study costs and time to compile dossier, and then the time/cost during the evaluation.
31 National fees today Type of application/fees Registration of a low risk biocidal product 1.000,00 Authorisation of a biocidal product 2.500,00 Provisional authorisation for a biocidal product containing an active substance not on the market on 14 May ,00 Mutual recognition of an authorisation of a biocidal product 1.000,00 Mutual recognition of a registration of a low risk biocidal product 500,00 Recognition of a frame formulation 4.000,00 Authorisation of a biocidal product within an existing frame formulation 1.000,00
32 Fees charged by the ECHA The objective is 100% cost recovery for service Commission/ECHA estimates are that the Agency will be self-financing and receive 25 million in fees by Some examples: ECHA fee for approval of active substance: 120k ; 40K for additional PTs Renewal of approval will cost 40k for a full evaluation, or 15k for a limited evaluation. Union Authorisation fee: 80k per product plus 40k if comparative assessment is needed. Major change to a product autorisation: 40k Minor change: 15k
33 An industry extimation UA = ECHA ECA/RMS = ECHA annual fee (product) = National authorisation = Parallel application = (ECA + 26 MS) = (ECA + 13 MS) (authorisation + MR applications at the same time)
34 SMEs To develop a dossier for a product, plus the submission fees, can easily cost in excess of and needs supply from an approved active substance source. Mutual recognition offers the possibility to extend each product to other countries via links to third party marketing authorisations. Important to decide which products to defend, directly, and which to take as a marketing authorisation to maintain «own brands», locally. Also important to decide whether to defend in isolation or whether a task force is more appropriate
35 SMEs There is a political will to support SMEs within Europe. Fees charged are meant to reflect the work done to evaluate the dossier which should be independent of the financial resources of the applicant because the standards and data requirements are the same. In its draft guidance on the fees payable to the ECHA, COM proposes some reductions for SMEs, while recognising that the biocides market is dominated (estimated 70%) by SMEs (very different to Plant Protection)
36 Data-sharing issues The current BPD has no mechanism for mandatory data sharing. The revision will impose mandatory data sharing for vertebrate animal study and set up an efficient dispute resolution mechanism, also aligning with Reach criteria. Data compensation could be left to national courts and reference is made to REACh guidance.
37 Data property BPD meant that as long as one company defended an active for a specific use (product type, PT) then any other company could continue to sell the same active, without contributing to any of the costs (studies, fees, dossier compilation, dossier defence). Subsequent EU legislation (REACh) began with the «no data, no market» principle so only companies that notified substances (via task forces, or «Substance Information Exchange Fora», SIEFs) could place those substances on the market. The EU Commission undertook to resolve this issue in the new Regulation (but not in the«mini-revision» till 2014)
38 Data property From the 1 st September 2013 any person wishing to place active substances on the Union market or in biocidal products shall submit a dossier, LoA or reference to a dossier (if protection periods have expired). The Agency will publish a list of persons that have made submissions of a dossier and includes the participants in the work programme. As of 1 st September 2015 no biocidal products on the market unless the active substance is from a person on the published list of participants. New applicants have the opportunity to gain access to the data needed to become an approved source, in return for a compensation payment for toxicological and ecotoxicological studies including any studies Roma not 6 novembre involving 2012 tests on vertebrate animals.
39 The free-rider issue While defended, any actor can place an AS on the market during the transitional period Transitional period is taking longer than expected 2010 > > >??? Complying companies are put at a disadvantage
40 BP with non-eu evaluated AS source Under BPD and BPR, responsibility for compliance is with the person placing on the market No system of Only Representative Art 95 of BPR: importer of a BP needs to be listed as source for the AS
41 The free-rider issue As of 1 Sep 2013, companies placing on the market: An AS, or a BP containing an AS Need to comply with the data requirements LoA New complete dossier From 2015, BP can only contain an AS from a compliant source
42 Treated articles Definition: "treated article" means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products A TA can be placed on the market only if it is treated with or incorporates approved AS or in Review Program Transitional measure: Possibility to submit dossier on new AS until 1 Sep 2016
43 Treated articles Labelling: Instructions for use where necessary to protect HH/ENV - Upon request by consumer, provide information on biocidal treatment, within 45 days Specific labelling is required if: a claim is made regarding the biocidal properties of the TA, or the conditions associated with the approval of the active substance(s) so require
44 Treated articles Specific labelling: a statement that the TA incorporates biocidal products; where substantiated, the biocidal property attributed to the TA; the name of all active substances contained in the biocidal products; the name of all nanomaterials contained in biocidal products, followed by the word "nano" in brackets; any relevant instructions for use
47 Frame formulation BPD Specifications for a group of biocidal products having the same use and user type. This group of products must contain the same active substances of the same specifications, and their compositions must present only variations from a previously authorised biocidal product, which do not affect the level of risk associated with them and their efficacy. In this context, a variation is the allowance of a reduction in the percentage of the active substance and/or an alteration in percentage composition of one or more non-active substances and/or the replacement of one or more pigments, dyes, perfumes by others presenting the same or lower risk, and which do not decrease the efficacy.
48 Biocidal Product Family BPR A group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products; a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk. The classification, hazard and precautionary statements for each product shall be the same (exception for a concentrate for professional use and ready-to-use products obtained through dilution).
49 Frame formulation Comparison Use Same use and same user type Similar use Composition Reduction of the active; Alteration in percentage of nonactive substances; Replacement of pigment, dye or perfume. Biocidal Product Family Elimination of an active in a multi-active product; Reduction of one or more active substances; Elimination of one or more nonactive substances; Variation of one or more nonactive substances; Replacement of one or more nonactive substances. Risk and efficacy Same or lower risk No decrease in efficacy No adverse effect on level of risk No significant reduction in efficacy
50 Benefits of BPF to FF: a CEFIC approach One application - one authorisation for whole family Mutual recognition of a BPF 30 day notification period before placing on the market of existing products in a family or changing pigment, dye or perfume No limit on the number of products in a BPF Broad variation on composition possible across a BPF
51 Industry survey
52 Setting up a BPF I. Group products according to active substances II. Divide active substance groups according to use III. Determine if a BPF can be formed from these subgroups using classification, efficacy and hazard profiles IV. Check for overlaps between the groups
53 Preparing for authorisation Decision on representative worst case(s), e.g.: High active concentration, or multiple actives Worst hazard profile Major commercial product Broad use spectrum/exposure scenario Establish testing programme minimum to support BPF Explore read-across and data-waiving
54 Sustainable use for biocides Need for risk management of non-agricultural pesticides Harmonise regulatory standards High level of protection for humans, animals and the environment Biocidal products should not be placed on the market for use unless they have complied with the relevant procedures of the Directive Apply simplified procedures where appropriate Encourage low risk products. Provide common principles for evaluation and authorisation to ensure a harmonised approach among member States Co-ordination with other EU legislation (eg PPP) Introduce the comparative approach in favour of less harmful products
55 Low risk substances An objective of the Directive was to encourage the use of low risk substances and the development of low risk products. The current BPD provides for simplified procedures of authorization for low risk substances (Annex IA and Annex II (B)). However, such procedures have never been used so far. The revision will repeal them and replace them by a system of direct authorizations for low risk products at the EU level, aligned with the REACH exemption regime.
56 Substances of concern Active substances can be added to Annex I if there is evidence that they do not give rise to concernas determined by CLP: Explosive/highly flammable Organic peroxide Acutely toxic of category 1, 2 or 3 Corrosive of category 1A, 1B or 1C Respiratory sensitiser Skin sensitiser Germ cell mutagen of category 1 or 2 Carcinogen of category 1 or 2 Human reproductive toxicant of category 1 or 2 Specific target organ toxicant by single or repeated exposure Toxic to aquatic life category 1 Fulfil any of the substitution criteria Roma Have 6 novembre 2012 neurotoxic or immunotoxic effects
57 Articles 24-26: Eligibility, application & making available of products in accordance with the Simplified authorisation procedure (SAP) Authorisation of Low Risk products To be eligible the active substance should be included in Annex I, contain no substance of concern, no nanomaterial, effective and does not require personal protective equipment. An application is made to the Agency and the evaluation is 90 days. A biocidal product SAP authorised may be made available on the market in all Member States without the need for mutual recognition. Authorisation holder shall notify each Member State no later than 30 days before placing on the market.
58 ECHA new roles approval of an active substance by submitting a dossier to ECHA authorisation of biocidal products /union authorization evaluation of technical equivalence alternative suppliers list EU product database BPR task forces support to MS and Ind
59 Why central Agency will be ECHA To take on the role of project manager To expedite review of «simple» dossiers via Union Authorisation (UA) To reduce time to market To ensure consistency of reviews and dossier quality To keep the evaluations to the prescribed timeline Creation of one BP Committee and 3 working groups (HH/ENV/Gen)
60 ECHA : BPR Implementation task forces Several working groups working on particular aspects for implementing BPR.Among these: Fees Cumulative and synergic effects Use phase products QSARs Substances of concerns Sustainable use.and many others
61 Setting National Help desk ECHA survey on possible feasibility of supporting helpdesk at national level has been already performed, result waited by the end of this year
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