Overview of the Biocidal
Product Regulation
The Seminar to Japanese Industry on theEU Chemicals Legislation: REACH, CLP &BPR

3 April 2015 / Tokyo, Japan
Petteri Mäkelä
ECHA International Relations

New Regulation
Biocidal Product Regulation (EU)•528/2012
oReplaces the Biocidal products
Directive (98/8/EC)••

Adopted in May 2012
Entered in the operation 1
September 2013

•Link to the text via ECHA website
http://echa.europa.eu/regulations/biocidal-products-regulation• Covers biocidal products not
regulated by:opesticides, veterinary medicines, cosmetics
legislation

PUBLIC2

Why from Directive to Regulation?
• Improve the functioning of
the EU market for biocides• Ensure high level ofprotection of human healthand the environment• Simplifies and streamlines
processes• Reduces animal testing
oCompulsory data/cost sharingoEncourages more flexible andintelligent approach to testing
PUBLIC3

Regulation vs. Directive• New definitions cover:oin situ generation

oplacing on the market

onanomaterials• Requirements for treated articles• Hazard based exclusion & substitution• Detailed procedure for mutualrecognition• Union authorisation of biocidal
products possible• Harmonised ”summary of the productcharacteristics” for authorisation
PUBLIC

Directive Regulation
98/8/ECEU 528/2012

Annex Iinclusion

Approval

Annex I

List ofapproved
substances

Annex IAAnnex I

Low-riskproducts

Products eligible
for the simplified
procedure

Frame
formulation

Biocidal productfamily4

ECHA & BPR• Coordination of procedures & centralisationof tasks that are better dealt at EU level rather
than at each Member State
Secretariat

evaluations

IUCLID

Industry

Biocidal ProductCommittee (BPC)

Helpdesk & guidance

MemberStates

opinionsRegister forbiocidal products

EUCommission

BPC Chair

Approval active substances

Review Program
Union authorisation
Other scientific opinions

Coordination Group
Technical equivalence

Secretariat

Alternative suppliers
Data sharing

applications

Dissemination

Board of Appeal

PUBLIC5

Basic Concepts• Active substance: a substance or a
micro-organism that has an action on oragainst harmful organisms - Approved
oHarmful organism: an organism, including pathogenic agents,
which has an unwanted presence or a detrimental effect onhumans, their activities or the products they use or produce,on animals or the environment• Biocidal products - AuthorisedoSplit into 22 Product Types (Annex V)

PUBLIC6

Main groups and product types• Disinfectantsohuman hygiene (1), public health (2), veterinary(3), food and feed areas (4), drinking water (5)• Preservatives
oin-can (6), film (7), wood (8), fibre (9),construction material (10), liquid cooling (11),slimicides (12), metal working fluids (13)• Pest controlorodenticides (14), avicides (15), molluscicides(16), piscicides (17), insecticides (18),repellents (19), other invertebrates (20)

• Otheroantifouling products (21),embalming/taxidermist fluids (22)PUBLIC

7

Legislative situation• Review ProgrammeoPhasing existing active substance Product Typecombinations into EU systemoPhasing in existing biocidal products via authorisation
into EU system• All non-approved active substances andconsequently non-authorised biocidal
products have to be removed from the market
Ø EU market is in a transitional phase up to the end of theReview Programme8

ECHA’s role
• Centralised IT systemØRegister for Biocidal Products R4BP 3(hub for all applications)ØIUCLID 5.6 including biocides functionalities.

• Biocidal Products Committee andCoordination GroupØCentral bodies for an EU-wide approachØScientific and administrative support to membersØAssure quality, consistency and transparency• Support to applicants and Member StatesØProvide guidance and an ECHA Helpdesk / Helpnet
ØPromote a consistent approach between Member States• Data sharing, dissemination and technical equivalenceØBenefit from REACH experience• CommunicationØAwareness raising with key actors and stakeholders
9Review of Actives – main steps
Competent authority report

Public consultation

Commenting phase

Only if candidate for substitution

Member States & applicant

Working group discussions
Efficacy

Phys-chem + analytical methods

Human health

Environment

Follow-up

Biocidal Products Committee
PUBLIC

Commission
decisionmaking10

Review Programme
Number of Active
Substance - Product-Typedossiers:•ooo••Total: 619
Approved: 109
In peer review process at EU level:
144

Annually reviewed around 50
dossiers
Extended from 14 May 2014
to 31 December 2024

11

Active Substance Approval
Faster process for all new applications:• One year evaluation stage• 270 days for opinion forming• Possibility of stopping the clock during evaluation• Up to 180 days; more if justified by the nature of thedata requested or by exceptional circumstances• Overall: around two years from submission ofapplication to BPC opinion• Followed by the European Commission implementing act
PUBLIC

12

Active Substances Exclusion of “SVHC”• Substances that:oare CMR (Carcinogens, Mutagens, or toxic for Reproduction
category) 1A or 1B, oroare PBT (Persistent, Bioaccumulative and Toxic), or vPvB
(very Persistent and very Bioaccumulative), oro

have ED (endocrine-disrupting) properties• “SVHC” cannot be approved as Active
Substances unless:
oExposure is negligible, oro

The substance is essential to control a serious danger tohuman or animal health or to the environment, oro

Non-approval will have disproportionate negative impact forsociety
PUBLIC13

Active Substances substitution• If an active substance is a candidate for
substitution
è Biocidal product is subject to comparative assessment• 60-day public consultation by ECHA:o

Third parties to provide relevant informationoMainly information on available substitutes expected• Explicit evaluation of the criteria in CompetentAuthority Report
oOnly the final outcome of assessment will confirm
whether criteria are met

PUBLIC14

Data sharing is mandatory• Submitted to ECHA via R4BP
• Minimise testing on animals & monopolistic situations ofsuppliers of Active Substances• Applies to:oData from tests on vertebrate animals on all tox- and ecotox studies for existing active substancesowith regards to alternative suppliers• Prospective applicant & data owner must seek agreement• Compensation for data is determined in a fair, transparent
and non-discriminatory manner, share the cost ofinformation to be submitted for this regulation• If negotiation fails, ECHA gives prospective applicant rightto refer, and proportionate share of the cost to be paid
fixed by national courts
PUBLIC

15

Active Substances Cost Sharing• All active substance manufacturers or importers
must submit a dossier or a letter of access to
ECHA as of 1 Sep 2013
• ECHA will establish a list of manufacturers orimporters who complied with this obligation• From 1 Sep 2015: only biocidal products with alisted source of Active Substance can be madeavailable on the market• Data protection for existing substances in thereview programme expires 31 Dec 2025 at thelatest

PUBLIC

16

Biocidal Products – a 2-step approach

Biocidal Product

Active SubstanceCommission

MS 1

MS 2

MS 3

EUEU positive list

Step 1

Step 2

Approval of Active
Substance per Product
Type combination

Product authorisation on national orUnion level

PUBLIC17

Union Authorisation• Authorisation given by the European
Commission, valid on the entire Union market• For single biocidal products or productfamilies with similar conditions of use across EU• Excluded:oProducts containing substances fulfilling theexclusion criteria

oProducts to control rodents, birds, fish, andother vertebrates (PTs 14, 15, 17 and 20)

oAntifouling products (PT 21)

18

Union Authorisation
Transition

Timeline

1. Step

2. Step

3. Step

1 Sept
2013:

1 Jan
2017:

1 Jan
2020:

PT 1, 3,4, 5, 18
and 19BPcontaining newactivesubstances

PT 2, 6and 13

Allremaini
ng PTs(besidethoseexcluded)Pre-submission
Eligibility check – 180 d
Submission
Validation – 30 d
Evaluation – 365 d
ECHA committee phase – 180 d

Commission decision

19

Union Authorisation Advantages• Facilitates the making available of biocidal
products with similar conditions of use on theEU market
oSimplifies procedures for economic operators targeting several
Member State markets

oReduces the overall administrative burden

oSingle authorisation for the entire Union market will have apositive impact on product availability.

oFixed deadlines will provide more certainty for applicants.

oHarmonised procedures will improve consistency in the dossiers’assessment.

20

Biocidal Products Mutual Recognition• Clear procedures including mechanisms to dealwith objections and derogations, for better
enforcement• Options:oin sequence: application when product is alreadyauthorised in one Member State, oroin parallel: application when product is not yetauthorised• 90 days for Member States to coordinate & agree• If no agreement, then Commission decides
oDisagreements referred to the Commission, possibly
based on ECHA opinion
PUBLIC21

Biocidal Products Simplified Procedure• Facilitates the marketing of product with lower
concern/better profiles with regard to health &environment:
oAll Active Substances listed in Annex IoContain no substance of concern or no nanomaterialsoSufficient efficacy

oNo need to wear PPE (Personal Protective Equipment)• Benefits for product authorisationoFaster procedure: Member State evaluation in 90 days

oOnce given by one Member State, the product can bemade available on the whole EU market, after a
Notification to ECHAPUBLIC

22

Comparative assessment of Products• During the assessment of the authorisation of:oBiocidal Product oro

Renewal of authorisation (either at Member State or EU level)• Products containing candidates for substitution
will not be authorised if alternatives:
oPresent significantly lower riskoAre sufficiently effective, ando

Present no significant economic or practical
disadvantage, ando

Chemical diversity adequate to minimise resistance

PUBLIC23

Product Authorisation Summary
Authorisation of Biocidal Products for a maximum of
10 years

PUBLIC24

Treated articles• DefinitionoSubstance, mixture or articleoTreated with or intentionallyincorporating biocidal products• Active substance inbiocidal product with which
the article is treated needs
to be approved in the EU• Technical guidance isbeing developed

PUBLIC

25

Treated articles
Conditions for placing on
the market•oArticle has to comply with all
relevant conditions of approval of
the active substance

Substance/producttype combinations thathave not yet been
approved are allowed if•oCombination is still in the review
programme, oro

An application for approval issubmitted before 1 September 2016

PUBLIC26

Treated articles - labelling• Required ifo

Claim is made regarding biocidal
properties of the article, oroConditions of substance approvalso require• Information to be provided
in the national languageoStatement that article incorporates abiocideo

Biocidal property of the articleoName of all active substances &nanomaterials

oInstructions for use where necessary toprotect man or environment
PUBLIC27

IT tools for BPR

R4BP3 and IUCLID: common hub
and paperless system
PUBLIC28

http://echa.europa.eu/regulations/biocidal-products-regulation
PUBLIC

29

ECHA Helpdesk advice on BPR
Customer: Applicants, particularly SMEs

Topics: Approval of Active Substance, inclusion inAnnex I, Union authorisation

Scope: Advice

Communication: Helpdesk contact form
http://echa.europa.eu/contact/helpdesk-contact-form
PUBLIC30

Biocides Guidance

http://echa.europa.eu/web/guest/guidance-documents/guidance-on-biocides-legislation
PUBLIC

31

Achievements BPR & PIC
Biocides• R4BP3 updated IT tool for biocidal applications• Electronic submission & storage system•Changes in the regulatory system clarified to duty holders•New regulatory processes proven to work
•Active substances review programme• 34 opinions in 2014

PIC
•Smooth take over of the regulation•New ePIC IT-tool for export and import notifications•Successful management of notifications• Around 4,600 in 2014
PUBLIC32

ECHA & industry challenges in 2015
Biocides•Company applications for active substance
supplier status by 1 September• Products not covered will be out of the market•Planning activities related to biocides under
uncertainty regarding the volume of applications andrelated fee income•Union authorisation• new opportunities for companies• New process for ECHA to manage

PUBLIC33

Worth to Remember• BPR streamlines the processes &enhances the decision making• Opportunities for businesses, but
companies need to learn andunderstand their duties and timelines• ECHA provides companies withsupport, IT tools & guidance• Pay attention to the requirements fortreated articles & alternative
suppliers

Thank you !