An Introduction to Exponent International Ltd.

and Active Substance Authorisation for Ozone under

the Biocidal Products Regulation

for

OZONE INDUSTRIES

18 November 2014

Presented by

Karen Howard and Fiona Crawford

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Introduction to Exponent

What Exponent can do for you

Ways of working

Biocide capabilities

Our services - Biocides

Biocidal Products Regulation (BPR)

• New Active Substance Procedure

• Core Data Requirements for an Active Substance (AS)

• Additional Data Requirements for AS PTs 2 & 4

• Indicative Costs for AS and Representative Product(s) Dossier

• Task Force Management

• Product Dossier Requirements

• Additional Product Dossier Data Requirements - PTs 2 & 4

• Management of in situ generated active substances in the context of the BPR (CA-Nov14-Doc.4.1 )

• Biocidal Product Families (BPF) - Art 3(1)(s)

• Product Authorisation

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Exponent is a multi-disciplinary Consulting Company

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EU (Exponent International Ltd.) • 50+ staff • Extensive regulatory expertise gained from working in industry,

independent regulatory consultancies, Regulatory authorities, contract research laboratories giving us a unique perspective on dealing with regulatory requirements and problem solving

• Languages spoken: English, French, Italian, German, Spanish,

Arabic, Catalan

USA • 40+ staff • Background EPA/FDA regulatory, industry, academia, consulting

ISO 9001:2008 certified

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A consultancy with scientists specialising in risk assessment and

registration of:

• Biocides

• Pesticides

• Industrial chemicals

• Cosmetics

• REACh

• Classification, Labelling and Packaging

• Safety Data Sheets

• GHS / CLP

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Work as part of your team, providing additional high-quality expertise to

enhance and compliment your in-house capabilities

Provide organisational capacity within multi-disciplinary teams to

address multiple projects

Provide high level problem solving capabilities

Advise and/ or act as a sounding board on potential courses of action

and strategies

Provide a “neutral viewpoint” to obtain views on particular issues from

Regulatory authorities, without the need to disclose your identity or

compound of interest

Work flexibly on issues of concern to meet time and budget

requirements

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Conflict check prior to undertaking project

• Resolution of conflicts

Written quotation

• As formal as required by client

Dedicated Project Manager

• Single point of contact for client

• Monthly update

• Progress of project

• Budget information

Payment

• Monthly invoices based upon work conducted

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Priority Lists Submission Deadline Product Types

First 28 Mar 2004

08 Wood Preservatives

14 Rodenticides

Second 01 May 2006

16 Molluscicides

18 Insecticides, acaricides & products to control other arthropods

19 Repellents and attractants

21 Antifouling products

Third 01 Aug 2007

01 Human hygiene biocidal products

02 Private area/public health area disinfectants & other biocidal products

03 Veterinary hygiene biocidal products

04 Food and feed area disinfectants

05 Drinking water disinfectants

06 In-can preservatives

13 Metalworking-fluid preservatives

Fourth 01 Nov 2008

07 Film preservatives

09 Fibre, leather, rubber and polymerised materials preservatives

10 Masonry preservatives

11 Preservatives for liquid-cooling and processing systems

12 Slimicides

15 Avicides

17 Piscicides

22 Embalming and taxidermist fluids

20 Control of other vertebrates

Exponent staff have prepared dossiers to support the Product Types shown in red

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Competent Authorities previously worked with:

Australia Austria Belgium Bosnia

Bulgaria China Czech Republic Croatia

Cyprus Denmark Estonia Finland

France Germany Greece Hong Kong

Hungary Ireland Italy Japan

Latvia Lithuania Luxembourg Malta

Netherlands New Zealand Norway Poland

Portugal Romania Russia Serbia

Singapore Slovakia Slovenia South Africa

Spain Sweden Switzerland Taiwan

UK

Full biocidal product dossiers submitted

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Expertise in:

Chemistry, Efficacy, Toxicology, Environmental fate, Ecotoxicology

Completeness checks

• Review of existing data, data gap analysis

Strategic decisions regarding:

• Data waivers and bridging arguments

• Biocidal product family assessments

Study placement and monitoring

Human health and environmental risk assessments and modelling

Dietary risk assessment – where appropriate

Technical equivalence assessments

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Human and Environmental Risk Assessments

• Advice on appropriate routes of potential human and environmental exposure

• Interpretation of core and additional data

• Derivation of appropriate effects endpoint

• Exposure assessments

• Integration of exposure with effects endpoints to produce risk assessments

• Assessment of Margins of Exposure (MOE) / Margins of Safety (MOS) and PEC/PNEC ratios

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• TNsG (BPD Technical Notes for Guidance)

• BEAT (Bayesian Exposure Assessment Tool)

• ConsExpo

• EASE (Estimation & Assessment of Substance Exposure)

• ECETOC-TRA v 2&3

• POEM/ EUROPOEM (Predictive Operator Exposure Model)

• RiskOfDerm

• Stoffenmanager

• EMKG/BauA-COSHH

• MEASE

• WPEM (Wet Paint Exposure Model)

• EFSA (European Food Safety Authority multi-diet spreadsheet model)

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ESD (Emission Scenario Document)

• PT 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, 19, 21

EUSES (EU System for the Evaluation of Substances)

FOCUS (Forum for Co-ordination of pesticide fate models and their

USe)

• Surface Water: STEPS1-2, SWASH, MACRO, PRZM_SW,

TOXSWA

• Groundwater: MACRO, PEARL, PELMO, PRZM_GW

OECD ESDs

ECETOC-TRA

MAMPEC (Marine Antifoulant Model to Predict Environmental

Concentrations)

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Successfully supported products and regulatory strategies to EU

Regulators

• Minimising additional data requirements and client costs

Significant issue / problem solving

• e.g. toxicology strategy where major lack of data; refinement of

human health and environmental risk assessments; strategies and

scenarios for dealing with unfavourable PEC/PNEC ratios

Major waiving argumentation accepted

• e.g. reproductive tox, carcinogenicity, ADME, dermal adsorption,

method validation, photodegradation, chronic aquatic ecotox, toxicity

to plants, terrestrial bioaccumulation, food and feedingstuffs, use of

existing higher tier studies to address core data points, read-across

to structurally similar substances

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Peer review and independent views on client dossiers prior to submission

Preparation of submissions for:

• National Registration

• Global Registration

• Product Authorisation (BPR)

• Mutual Recognition (BPR)

Dossier submission tools

IUCLID (International Uniform Chemical Information Database)

• Extensive experience of IUCLID for REACh registrations and now using IUCLID 5.5

for biocides active and product dossiers

• IUCLID also used for Technical Equivalence dossiers and for generating SPC, CLP

dossiers

R4BP (Register for Biocidal Products)

• Routinely using R4BP3 for submissions - information on progress of authorisation,

communication with the authorities, date of Product Authorisation made available to

other MS and the Commission

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Liaison with competent authorities during evaluation process

Defence of waiving argument and risk assessment strategy

Study monitoring of additional data requested by the Competent Authority

• Placement and monitoring of contract laboratory testing

• Reviewing protocols and study reports

Collation / summation of additional data and / or information requested by the Competent Authority

Attendance at Competent Authority meetings, Technical Meetings/ Biocidal Product Committee (BPC) Meetings

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ECHA receives and validates the dossier

The evaluating competent authority carries out the completeness

check and dossier evaluation within 455 days (assuming no data

gaps).

The draft assessment report is sent to the applicant through R4BP 3.

The applicant has 30 days to provide written comments.

The updated assessment report is transmitted through R4BP 3 to

ECHA for peer review in the Biocidal Products Committee (BPC).

The BPC has 270 days to deliver an opinion through a peer review

assessment and to submit this opinion to the Commission.

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BPR No. Information, test or study required for active substance

1 APPLICANT

2.

IDENTITY OF THE ACTIVE SUBSTANCE

For the active substance, the information given in this Section shall be sufficient to enable the

active substance to be identified. If it is not technically possible or if it does not appear scientifically

necessary to give information on one or more of the items below, the reasons shall be clearly

stated

3. PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE

4 PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS

5 METHODS OF DETECTION AND IDENTIFICATION

6 EFFECTIVENESS AGAINST TARGET ORGANISMS

7 INTENDED USES AND EXPOSURE

8 TOXICOLOGICAL PROFILE FOR HUMAN AND ANIMAL INCLUDING METABOLISM

9 ECOTOXICOLOGICAL STUDIES

10 ENVIRONMENTAL FATE AND BEHAVIOUR

11 MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT

12 CLASSIFICATION, LABELLING AND PACKAGING

13 SUMMARY AND EVALUATION The key information identified from the endpoints in each

subsection (2-12) is summarised, evaluated and a draft risk assessment is performed

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Product-type specific additional information requirements for active substances (BPR Annex II) PT2 PT4

9.1.3. Growth inhibition study on algae

9.1.6.1. Long term toxicity testing on fish

9.1.6.2 Long term toxicity testing on invertebrates

9.2.1 Effects on soil micro-organisms X

9.2.2. Effects on earthworms or other soil-dwelling non-target invertebrates X

9.2.3. Acute toxicity to plants X

9.3.1. Reproduction study with earthworms or other soil-dwelling non-target invertebrates X

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Approval required based on Article 93 of the BPR

“Ozone generated from oxygen” will be the active substance

“Pure oxygen” or “oxygen in the atmosphere” (as appropriate) will be regarded

as the biocidal product and will need to be authorised as such.

Submission deadline 1 September 2016

Precursors for in situ generated ozone can be placed on the market and in situ

generated ozone can be used until 1 September 2017, if no application for the

approval of ozone is submitted by

1 September 2016.

Generation route to be considered as well as application route

Technical Equivalence

• Similarity to be confirmed regarding chemical composition and hazard profile of

active substance releasers

• In this case drinking water standards could be referenced

Article 95

• Refers to the name of the active substance releaser

Strategy for dossier submission

Literature Search and data gap analysis

Data generation if required

Dossier preparation

• Human health and environmental risk assessment – at least 2 major scenarios (PTs 2 and 4)

• Dossier preparation: all sections of IUCLID

• Dossier Submission

• project management

ECHA fees

• 120,000 Euros - for the first product-type for which that active substance is approved

• 40,000 Euros - additional fee per additional product type

• 10,000 Euros - for the first inclusion in Annex I of an active substance

Evaluating MS fee

• Dependant upon Member State e.g. NL 212,500 Euros; UK 190,000 GBP

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2014/2015: Establishment of strategy

2015: Begin data generation if necessary

2015: Risk assessments, data generation & dossier preparation

2016: Dossier preparation & submission

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Exponent is experienced in Task Force/Consortia Management

Communication is considered key to a successful working relationship

One point of contact, with support as necessary

Agreements

• Consulting agreement with the Task Force

• Individual non-disclosure agreements with each company

Invoicing

• Exponent usually issues a monthly invoice.

• Depending on the Task Force agreement invoices could be sent to a nominated

Task Force representative or to each individual company Task Force member.

Payment of Submission Fees

• Exponent may pay the Regulatory fee on behalf of the Task Force, however, we

would require advance payment of the fee by the Task Force.

Task Force or CA Meetings

• Travel to meetings is billed at 50% of the hourly rate for the individuals concerned.

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Physical and Chemical Properties

• Analysis of the a.s. within the BP

• Storage stability of the BP

• Technical characteristics of the BP

Efficacy

• Efficacy Guidelines for Disinfectants under preparation

• BP Dossiers must include Efficacy to demonstrate support of label claims

Environmental Risk Assessment

• Environmental hazards & classification of BP

• Detailed uses of BP & instructions for use

• Emissions to the environment

• Conditions/restrictions under a.s. Annex inclusion

Human Health Risk Assessment

• Human health hazards & classification of BP

• Detailed uses of BP & instructions for use

• How/when might this impact on any person who my come into contact with the BP

• Conditions/restrictions under a.s. Annex inclusion

Access to active substance data

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Additional Product Dossier Data requirements for Product Types 2 and 4

In addition, further information on the release due to the use of the product is needed:

10.1 Foreseeable routes of entry into the environment on the basis of the use envisaged

• In addition to the data to be submitted as core data, information should be supplied for

disinfectants in general, on how and in what percentage the active substance, its

transformation products or the other ingredients in the product are released from the point

treated during use and during washing, etc. (e.g. per unit of surface area per unit of time) by

evaporation, dissolving in water or another way. Release rates to be given can be either

default estimates or measured.

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• Biocidal Product Family means a group of biocidal products having: (i) similar uses; (ii) the same active substances; (iii) similar composition with specified variations; and (iv) similar levels of risk and efficacy;

• Meta SPC concept – group of products within the BPF having:

• Similar compositions within a specified variation, which falls within the specified variations of the whole BPF

• Similar uses covered by the same levels of risk and efficacy • Same Classification and Labelling i.e. hazard and precautionary

statements are the same • Same information on first aid instructions, disposal, storage and

shelf life

• Currently under discussion

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In order to obtain a product authorisation (PA), the a.s. must be approved for use in the relevant product type

National authorisation

• Submit to one Member State Competent Authority (MSCA)

Mutual recognition (MR)

Submit to one Reference MS and the other concerned MSs

• in sequence

• or in parallel

• MR process takes ~ 5 months from validation of application by the

evaluating MS

Union Authorisation

• Authorisation for every MS - not necessarily the most cost effective

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National authorisation (Art. 29)

Submit to one MSCA - must not apply to other MS for national

authorisation for same biocidal product for same use(s)

MSCA accepts application

or

If MSCA considers that the application is incomplete, applicant given

90 days to submit further data

Authorisation will take at least 425 days (without the need to submit

further information)

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Mutual recognition in sequence (Art. 33)

• National authorisation already granted by the Reference MS

• Need to submit an application to each competent authority of the

Member States concerned including a translation of the national

authorisation granted by the Reference MS local language

• Authorisation likely to take 150 days

Mutual recognition in parallel (Art. 34)

• The applicant submits an application to the Reference MS at the

same time as each of the concerned MSs for which mutual

recognition is applied

• Authorisation likely to take at least 515 days

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National Authorisations (Art 29) Time Overall min Overall max Comment

Step Description (d) (d)

1 Submission to MSCA

2 MSCA to inform applicant of fee

3 Applicant pays fee within 30 days of step 2

30 30 30

4 MSCA accepts application + validates within 30

days of step 3. 30 60 60

Applicant must not have applied to any

other competent authority for a national

authorisation for the same biocidal

product for the same use(s)

If MSCA considers that the application is

incomplete, it informs applicant of what additional

information is required + applicant has 90d to

submit further data

90 150

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MSCA decides to grant an application within 365 d

of step 4, taking into account the comments of the

applicant (30 days). A possible suspension of up

to 180 days during the evaluation period if further

data need to be generated.

365 425 695

Years 1.2 1.9

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CA fees vary

Depends on countries in which you wish to market as CA fees differ

from country to country

Fees are set to ensure full recovery of cost

UK

• Modular approach to include coordination/administrative tasks,

chemistry, toxicology, operator hygiene, ecotoxicology, fate and

behaviour, efficacy data

• Fees range from £4950 to 11895 depending on the quantity of data

Ireland

• Authorisation fee €5000 + Biocidal Product Family fee €5000

(~£8000)

• Mutual recognition €2500 (~£2000)

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THANK YOU

ANY

QUESTIONS?

Exponent International Limited

The Lenz, Hornbeam Business Park, Harrogate, North Yorkshire, HG2 8RE ,UK

Tel: +44 (0) 1746 769228

Mobile: + 44 (0) 7887 622864

Skype: karen.howard_exponent

Website: www.exponent.com

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