An Overview on the New Biocidal Products Regulation: Asian-European Regulatory Summit Singapore 1st-2nd September, 2014 Dr David Dillon Director: Registration & Regulatory Compliance (Europe) SC Johnson
Introduction Brief Background Main Principles Approval of active substances Authorisation of biocidal products Treated Articles Mandatory data sharing Secondary (implementing) legislation Take home messages 2
The Biocidal Products Regulation Purpose: To increase the free movement of biocidal products within the Community Main Aims: Harmonisation of the market for biocidal products To ensure high level of protection for Humans and the Environment 3
EU Biocides Regulatory Framework Regulation (EU) No 528/2012 ( BPR ): entered into application on 1 st September 2013 It replaced and repealed the old Biocides Directive (98/8/EC) also known as BPD which entered into force in the EU on 14 th May 2000 BPR was itself recently amended by Regulation (EU) No 334/2014 as of 11 th March 4 2014
EU Regulatory Framework Main principles Authorisation required prior to placing on the market Approval of biocidal active substances at EU level National product authorisation with mutual recognition Industry responsible for submitting data allowing evaluation National rules apply during the programme for review of existing active substances 5
Directive vs Regulation: What will NOT change Approval of active substances (AS) at EU level Transitional derogation during substance evaluation Continuation of the programme for review of existing active substances National authorisation of biocidal products with Mutual Recognition Level of (data) requirements in applications, main principles for approval/authorisation Evolution rather than Revolution THE FUNDAMENTAL PRINCIPLES OF THE BPD WILL 6 NOT CHANGE UNDER THE BPR
Directive vs. Regulation: What WILL change (1) Hazard based exclusion and substitution criteria for active substances Union authorisation of biocidal products Authorisation with a harmonised SPC (Summary of Product Characteristics) Detailed procedure for mutual recognition (in sequence, or in parallel) Definition of nanomaterials, exclusion unless explicitly mentioned New provisions for treated articles 7
Directive vs. Regulation: What WILL change (2) Coordination role for ECHA Provisions for all active substance suppliers, costsharing by alternative substance suppliers Mandatory data sharing Biocidal Product Family (replaces the Frame Formulation Concept) New definition of Biocidal product: to cover in situ generation Placing on the market (= 1 st Supply) vs. making available on the market (= any supply, including the 1 st Supply) Introduction of new terminology and concepts 8
The European Chemical Agency (ECHA) Provide scientific and technical support Co-ordinate substance approval, Union Authorisation Secretariat for Biocidal Products Committee and the Co-ordination Group IT platform/tools (R4BP) Electronic submissions Data dissemination Data sharing Technical equivalence List of (alternative) suppliers of active substances 9 Help desk
Biocidal Products Regulation Two Part process Biocidal Active Substances Reviewed by rapporteur Member State on behalf of all EC. If included in approved list then can be used in biocidal products Biocidal Products Authorised in each Member State System of mutual recognition between Member States 10
Approval of active substances
Approval of AS: Exclusion criteria (Art 5) Objective: exclude substances of highest concern Substances that: Are Carcinogens, Mutagens, or Toxic for Reproduction Cat 1A or 1B, or Are Persistent, Bioaccumulative and Toxic, or very Persistent and very bioaccumlative, or Have endocrine-disrupting properties The Principle: The active substance cannot be approved 12
Approval of AS Exclusion criteria (Art 5) The derogation: Substances may nevertheless be approved if: Exposure is negligible The substance is essential to control a serious danger to human or animal health or to the environment, or Non-approval will have disproportionate negative impact for society If so: Risk mitigation measures to minimise exposure Authorisation only in MS where needed (no Union Authorisation) Approved for a maximum of 5 years 13 Targeted by the substitution provisions
Approval of AS Substitution (Art 10) Objective Substitution of substances of high concern A substance is a candidate for substitution if: Fulfils the exclusion criteria (but has nevertheless to be approved) Is a respiratory sensitiser Has significantly lower Acceptable Daily Intake, Acceptable Reference Dose or Acceptable Operator Exposure Level than similar substances Meets two P/B/T criteria Gives concern linked to critical effects (e.g. high potential risk to groundwater), or Contains a significant proportion of non-active isomers or impurities Approved 14 for a maximum of 7 Years
Authorisation of BPs:-Comparative Assessment (Art 23) Consequences of substitution of AS Made during the assessment of the authorisation of the BP or the renewal of authorisation Products containing candidates for substitution will not be authorised if Alternatives Present significantly lower risk are sufficiently effective, and Present no significant economic or practical disadvantage, and Chemical diversity adequate to minimise resistance Possible derogation for a maximum 4 years in order to gain experience Authorisation of BP for a maximum of 5 years 15
16 Inter-linkage between Exclusion Criteria, Substitution and Comparative Assessment
Authorisation of biocidal products
New Authorisation routes and options Union Authorisations National Authorisation + Mutual Recognition Mutual Recognition parallel + sequence Simplified authorisation procedure Biocidal Product Families 18
Mutual Recognition of Authorisations In sequence or in parallel 90 days for Member States to agree between them Unresolved disagreements referred to co-ordination group EU Commission to settle un-resolved disagreements Refusal or adjustment possible on grounds of: Protection of, e,g. environment or health Absence of target organism Refusal or adjustment subject to agreement with applicant or Commission decision 19
Authorisation of BPs: Union Authorisation Objective: Facilitate access to the entire EU market Authorisation given by the EU COM, valid across EU Products (or Product Families) with similar conditions of use across EU Managed by ECHA (though MSCA will perform the evaluation) Excluded: Products containing substances fulfilling the exclusion criteria Products to control rodents, birds, fish, and other vertebrates Antifouling products Progressive phase in period 20
Authorisation Procedures: Simplified authorisation procedure Objective: Promote products with lower concern for health and environment Conditions: Active must be listed on Annex I & satisfy any restrictions or specifications No SoC, No nano, no PPE, must be sufficiently effective Submission & evaluation process Simple Dossier Application form + efficacy report + Summary of Product Characteristics (SPC) No requirement for LoA Submission to Agency (ECHA) Evaluation by a MS within 90 days Once Authorised in One MS, notification to OMS is sufficient (30d) No Mutual Recognition Procedure 21
Annex I Substances eligible for Simplified Authorisation Procedure Category 1 Substances authorised as food additives acc. Regulation 1333/2008 Lactic acid, sodium acetate, sodium benzoate, (+)-tataric acid, acetic acid, propionic acid Category 2 Substances included in Annex IV to Regulation 1907/2006 Ascorbic acid, Linseed oil Category 3 Category 4 Category 5 Category 6 Category 7 22 Weak acids??? Traditionally used substances of natural origin Lavender oil, peppermint oil Pheromones Oct-1-en-3-ol, webbing clothes moths pheromone Substances included in Annex I or IA of Directive 98/8/EC Carbon dioxide, nitrogen, (Z,E)-Tetradec-9,12-dienyl acetate Other Baculovirus, bentonite, citronellal, iron sulphate
Biocidal Product Families 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 (Art. 3) Authorisation may be given for a product family and can cover all products within that family Notify MS CA 30 days before introducing new product within the family (Art. 17(6)) Changes to dyes, perfumes or pigments within existing family ranges do not need to be notified 23
Treated Article Provisions Objective: Protection of health and environment, level playing field between production within vs. outside of the European Union Allowed on the market only if all the active substances are approved (or are under evaluation under the review programme) for the relevant use Labelling requirement for certain articles, when 24 Claim is made regarding biocidal properties of the article; or Conditions of substance approval so require
Labelling of certain treated articles Required if: Case 1: claim is made regarding biocidal properties of the article, or Case 2: conditions of substance so require Information to be provided in the national language Statement that article incorporates biocides Biocidal property of the article Name of all active substances and all nanomaterials Instructions to protect man and environment, where appropriate Obligation for suppliers to give some information at the request of 25 a consumer within 45 days Free of charge
Mandatory Cost sharing As of 1 Sept 2013, all active substance manufacturers or importers to submit a dossier or letter of Access to ECHA ECHA to publish list of manufacturers Provisional list available at http:echa.europa.eu/information-onchemicals/active-substance-suppliers Mandatory data and fair costs sharing to apply to all the tox, eco-tox studies and e-fate Data Protection until 31 Dec 2025 Biocidal products containing existing active substances of manufacturers not listed by ECHA shall not be placed on the market after 1 Sept 2015 Storage and use of existing stocks allowed until Sept 2016 Competent Authorities to carry out official controls 26
Mandatory data sharing Objectives: Limit vertebrate testing, prevent competition distortions Data from tests on vertebrate animals All tox and eco-tox (and e-fate) studies for existing active substances for alternative suppliers and their clients Prospective applicant and data owner must seek agreement If negotiation fails, ECHA gives prospective applicant right to refer Fair compensation 27
Implementation Challenges 42 tasks foreseen directly in the BPR (delegated/implementing acts, guidelines, detailed rules etc.) Co-ordination COM/ECHA, involvement of MSCAs and IND Some tasks led by COM, others by ECHA Overview with priorities https://circabc.europa.eu/w/browse/7c9f6736-1cb1-451f-8ed1-d2bcfcaaa870 28
Implementation Measures Secondary legislation Regulation on changes to product authorisation : Reg. (EU) No 354/2013 of 18th April 2013 Regulation authorisation of same biocidal products : Reg. (EU) No 414/2013 of 6th May 2013 Regulation on fees to ECHA : Reg. (EU) No 564/2013 of 18th June 2013 Regulation on the extension of duration of review programme to 2024 : Reg. (EU) No 736/2013 of 17th May 2013 Regulation on the modification on data requirements (proof of technical equivalence in BP applications) : Reg. (EU) No 837/2013 of 25th June 2013 Regulation on the procedures for the inclusion of active substances into Annex I of the BPR : Reg. (EU) No 88/2014 of 31st January 2014 Regulation on the procedures for the renewal of authorisations by mutual recognition : Reg: (EU) No 492/2014 of 7 th March 2014 Regulation on the organisation of the review programme of active substances (to replace Reg. (EU) 1451/2007) : under discussion, for adoption by Autumn 2014 29
EU Commission Guidance Work on guidance documents or proposals on various topics: Proposal of management of nanomaterials https://circabc.europa.eu/w/browse/f2d79b34-2f5a-4bb4-97e8-b982c9def765 Guidance on fees payable to Member States https://circabc.europa.eu/w/browse/b5c900a2-ef66-4a46-996d-00d5a29aee9a Guidance on similar conditions of use, for the Union authorisation https://circabc.europa.eu/w/browse/2ac21f0f-d790-4667-9358-1bcd0db0b35e Guidance on treated articles https://circabc.europa.eu/w/browse/e1adf8de-0ad6-4484-84ec-80704391a038 Document on comparative assessment https://circabc.europa.eu/w/browse/d309607f-f75b-46e7-acc4-1653cadcaf7e Other Guidance under discussion : Borderline between biocidal products and cosmetics https://circabc.europa.eu/w/browse/6283ad7a-7416-4b83-a201-92ba58224222 In situ generation 30 https://circabc.europa.eu/w/browse/7f81cf6d-a333-441a-ab96-324c8d9de8a0
Challenges presented by new BPR New objectives New criteria New procedures Ambitious timelines Exclusion, substitution & comparative assessment Sustainable Use of biocides 31
Opportunities offered by BPR Simplification and Streamlining Procedures & Authorisation options o o Union Authorisation Mutual Recognition of authorisations o Simplified Authorisation Procedures o Biocidal Product Family o Changes to authorised products Changes Regulation o Same Biocidal Products
Take home messages BPR: largely built on the same foundations as old Directive A lot of work is on-going at EU level to aid the implementation of the BPR BPR introduces many challenges for Industry but also for COM/ECHA and the Regulatory Authorities BPR also introduces opportunities for further harmonisation, simplification, and streamlining of processes. THIS IS A PERIOD OF BIG CHANGE for all Actors in the Regulation of biocides in Europe 33
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