Overview of new Biocidal
Product Regulation Impacts on biocides &biocide-treated articles
imported into the EU
The Latest Trends in the EU
Chemicals Management: REACH, CLP & BPR

Petteri Mäkelä

New Regulation

B528/2012 P•

iocidaloroductRegulation (EU)

Replaces the Biocidal products
Directive (98/8/EC)•

Adopted in May 2012

•Entered in the•Link to the text via ECHA website

operation 1
September 2013
http://echa.europa.eu/regulations/biocidal-products-regulation•Covers biocidal products not
regulated by:opesticides, veterinary medicines, cosmetics
legislation
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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

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Regulation vs. Directive
Directive Regulation• New definitions cover:ooogeneration
placing on the market
nanomaterials
in situ• Requirements fortreated articles

98/8/ECEU 528/2012

Annex Iinclusion

ApprovalAnnex IList ofapproved
substances

Annex IA

Annex I

Low-riskproducts

Products eligible
for the simplified
procedure• Hazard based exclusion & substitution• Detailed procedure formutual•of biocidal

recognition
Union authorisation
products possible• Harmonised ”summary of the productcharacteristics” for authorisation

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Biocidal productFrameformulation family

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

evaluations

Industryapplications

bi R
oc egid ist
al e
pr rfood ructs
IUCLID

Helpdesk&gu
idanceSecretariat
BPC Chair

Biocidal ProductCommittee (BPC)
Approval active substances

Review Program
Union authorisation
Other scientific opinions

Coordination Group
Technical equivalence
Alternative suppliers

Secretariat

Data sharing
Dissemination

Board of Appeal

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Basic Concepts• Active substance: a substance or a
micro-organism that has an action on oragainst harmful organisms
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:
oSplit into 22 Product Types (Annex V)

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Main groups and product types• Disinfectants
ohuman 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 control
orodenticides (14), avicides (15), molluscicides(16), piscicides (17), insecticides (18),repellents (19), other invertebrates (20)

• Otheroantifouling products (21),embalming/taxidermist fluids (22)PUBLIC7

Review of Actives – main steps
Competent authority report
Public consultation

Only if candidate for substitution

Commenting phase

Member States & applicant

Working group discussions
Efficacy

Phys-chem + analytical methods

Human health

Environment

Follow-up

Biocidal Products Committee
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Commission
decisionmaking8

Review Programme•

ActiveSubstance - Product-Type
Number ofdossiers:oooo•

Total: 660
Approved: 70In peer review process at EU level:
160
Still to be submitted by Member
States: 430
Commission intends to decideon 30 dossiers in the second
half of 2013•

Extended from 14 May 2014
to 31 December 2024

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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 COM implementing act

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Active Substances Exclusion of “SVHC”• Substances that:ooo

are CMR (Carcinogens, Mutagens, or toxic for Reproduction
category) 1A or 1B, or
are PBT (Persistent, Bioaccumulative and Toxic), or vPvB
(very Persistent and very Bioaccumulative), or
have ED (endocrine-disrupting) properties• “SVHC” cannot be approved as Active
Substances unless:oooExposure is negligible, orThe substance is essential to control a serious danger tohuman or animal health or to the environment, orNon-approval will have disproportionate negative impact forsociety
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Active Substances substitution• If an active substance is a candidate forsubstitution

 Biocidal product is subject to comparative assessment• 60-day public consultation by ECHA:
oThird parties to provide relevant informationoMainly information on available substitutes expected• Explicit evaluation of the criteria in Competent
Authority ReportoOnly the final outcome of assessment will confirm
whether criteria are met

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Data sharing is mandatory• Submitted to ECHA•

Minimise testing

via R4BP

on animals & monopolistic situations ofsuppliers of Active Substances• Applies to:ooData from tests on vertebrate animals on all tox- and ecotox studies for existing active substanceswith regards to alternative suppliers• Prospective applicant & data owner must•

Compensation

seek agreementfor data is determined in a fair, transparent

and non-discriminatory manner, share the cost of
information to be submitted for this regulation• If negotiation fails, ECHA gives prospective applicant

to referright, and proportionate share of the cost to be paid

fixed by national courts
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Active Substances Cost Sharing• All active substance manufacturers or importers
must submit a dossier or a letter of access toECHA 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

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Biocidal Products – a 2-step approach
Biocidal Product

Active SubstanceCommission

EU positive listMS 1MS 2MS 3EU

Step 2

Step 1

Approval of Active
Substance per Product
Type combination
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Product authorisation on national orUnion level
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Union Authorisation• Authorisation given by the EU Commission, valid
on the entire Union market• For single biocidal products or productfamilies with similar conditions of use across EU• Excluded:ooo

Products containing substances fulfilling theexclusion criteria
Products to control rodents, birds, fish, andother vertebrates (PTs 14, 15, 17 and 20)
Antifouling products (PT 21)

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Union Authorisation
Transition

1. Step1 Sept
2013:

PT 1, 3,4, 5, 18
and 19BPcontainin
g newactivesubstancesTimeline

2. Step 3. Step
1 Jan
2017:
PT 2, 6and 13

1 Jan
2020:
All
remaining PTs(besidethoseexcluded)Pre-submission
Eligibility check – 180 d
Submission
Validation – 30 d
Evaluation – 365 d
ECHA committee phase– 180 d
Commission decision17

Predicted number of BPC opinions(DG-ENV February 2013)2013
LegalTime limit(days)

Approval of newactive substances
Approval ofexisting active
substances (RP)
Renewal of active
substance
approvals
Union
authorisation of
biocidal products
Amendments ofUnionauthorisations
Disagreement
mutualrecognition
Total

2014

2015

2016

2017

2018

2019

2020

2021

2022

270

0025555555270050

50505050

50

50

5050

270 (full)
90 (partial)

0233001812

120512

2377

7976

131

143

162

90

0

0001241220

27

120

030

30

303030

30

30

30

30

087

97

111

162

167

166

236

259

286

180

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Union Authorisation Advantages• Facilitates the making available of biocidal
products with similar conditions of use on theEU marketooooo

Simplifies procedures for economic operators targeting several

Member State markets
Reduces the overall administrative burden
Single authorisation for the entire Union market will have apositive impact on product availability.
Fixed deadlines will provide more certainty for applicants.
Harmonised procedures will improve consistency in the dossiers’
assessment.

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Biocidal Products Mutual Recognition• Clear procedures including mechanisms to deal
with 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

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Biocidal Products Simplified Procedure• Facilitates the marketing of product with lower
concern/better profiles with regard to health &environment:

Annex Ino substance of concern no nanomaterials
efficacy
PPEo

All Active Substances listed ino

Containo

SufficientoNoorneed to wear

(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

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Comparative assessment of Products• During the assessment of the authorisation of:oBiocidal Product oroRenewal 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 resistancePUBLIC

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

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

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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•ooCombination is still in the review
programme, orAn application for approval issubmitted before 1 September 2016
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Treated articles - labelling• Required ifo
Claim is made regarding biocidal
properties of the article, oro

Conditions of substance approvalso require• Information to be provided
in the national languageooooStatement that article incorporates abiocide
Biocidal property of the article
Name of all active substances &nanomaterials
Instructions for use where necessary toprotect man or environment
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IT tools for BPR

R4BP3 and IUCLID 5.5: common hub
and paperless system
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IUCLID 5.5 – key features for biocides• Biocidal productcomposition• 9 new data templates • Technical characteristics ofthe biocidal productfor BPR-specific• Phys-chem compatibility
informationwith other products
including other biocidal
products with which its use• New dossier types
is to be authorised• Product types and uses
• View for active• Released on 2April• Biocidal use tonnage• Toxicological profile forhumans and animals
including metabolism• Measures to protecthumans, animals andthe environment• Packaging• Summary & evaluation

substances & biocidal
products in line withnumbering of the BPR
info requirements
annexes

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http://echa.europa.eu/regulations/biocidal-products-regulation
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ECHA Helpdesk advice on BPR

Customer:
Topics:Applicants, particularly SMEs

Approval of Active Substance, inclusion inAnnex I, Union authorisation

Scope:

Advice and assistanceCommunication:

Helpdesk contact form, written

replies

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BPR

Expertiseareas
ACTIVESUBSTANCESRELATED

BIOCIDALPRODUCTS
RELATEDIDENTITY,PHYS-CHEM,ANALYTICEFFICACYRESISTANCE
UN-EFFECTSHUMANHEALTHVOLUME I

VOLUME II

VOLUME III

ASAS

BP

BP

CC

B
A

BP

ASC

B

A

ASC

B
A

C.
B.
A.
Information
Requirements

Evaluation

Risk
assessment

A.

B.

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B
A

Evaluation

BP

C

B
A

C.
Risk
Informationassessment
Requirements

GuidanceASC

B
A

VOLUME IV

BP

C

B
A

New
guidance
package

ENVIRONMENT

B
A

Self-explaining
structure

Concise andharmonised information
Up-to-date31

Publishing schedule 2013 & beyond• Guidance on information requirements Part A(July 2013)• Guidance on technical equivalence(1 Sep 2013)• Guidance on alternative suppliers(1 Sep 2013)• Guidance on procedural aspects in relation to active substances (by Q1 2014)• Guidance on procedural aspects in relation to biocidal products (by Q1 2014)• Guidance on mixture toxicity• Guidance on risk assessment – Human Health – part B• Guidance on risk assessment – Environment– part B• Guidance on micro-organisms• Guidance on efficacy assessment- part B• Guidance on phys-chem/analytics assessment- part B• Guidance on evaluation – part C of all 4 volumes• Guidance on various specific topics transferred from the BPD framework as
becomes available and depending on its importance (unless integrated in theoverall BPR structure)
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Worth to Remember about
Biocides Regulation• Streamlines the processes & enhances
the decision making• Opportunities for businesses, but
companies need to learn andunderstand their duties and timelines• ECHA provides companies with support,
IT tools & guidance• Pay attention to the requirements fortreated articles & alternative suppliers

Thank you !