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

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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

EU Biocides Regulatory Framework

Regulation (EU) No 528/2012 (“BPR”): entered into application on 1st September 2013 – It replaced and repealed the “old” Biocides Directive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 14th May 2000

BPR was itself recently amended by Regulation (EU) No 334/2014 as of 11th March 2014 4

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

EU Regulatory Framework Main principles

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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 NOT CHANGE UNDER THE BPR 6

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

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Directive vs. Regulation: What WILL change (2) Coordination role for ECHA Provisions for all active substance suppliers, cost-

sharing 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” (= 1st Supply) vs. “making available

on the market” (= any supply, including the 1st 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 Help desk

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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

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

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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 – Targeted by the substitution provisions

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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 for a maximum of 7 Years

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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

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Inter-linkage between Exclusion Criteria, Substitution and Comparative Assessment

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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

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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

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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

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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 Weak acids ???

Category 4 Traditionally used substances of natural origin Lavender oil, peppermint oil

Category 5 Pheromones Oct-1-en-3-ol, webbing clothes moths pheromone

Category 6 Substances included in Annex I or IA of Directive 98/8/EC Carbon dioxide, nitrogen, (Z,E)-Tetradec-9,12-dienyl acetate

Category 7 Other Baculovirus, bentonite, citronellal, iron sulphate 22

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

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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 • Claim is made regarding biocidal properties of the article; or • Conditions of substance approval so require

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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 a consumer within 45 days – Free of charge 25

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-on-

chemicals/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

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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

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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 7th 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

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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 https://circabc.europa.eu/w/browse/7f81cf6d-a333-441a-ab96-324c8d9de8a0 30

Challenges presented by new BPR

New objectives New criteria New procedures Ambitious timelines Exclusion, substitution & comparative

assessment Sustainable Use of biocides

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Opportunities offered by BPR Simplification and Streamlining Procedures & Authorisation options o Union Authorisation o 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

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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

THANK YOU FOR LISTENING!

ANY QUESTIONS??

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