The document discusses regulations around biocidal products in the European Union. It provides definitions and explains that under the Biocidal Product Regulation, all biocidal products must be authorized before being placed on the market. Applications require approval of both the active substances within biocidal products and of the products themselves, a process that typically takes at least two years. The deadline for existing biocidal products to complete authorization is September 2015.

1. The Biocidal Product Regula-
tion (BPR, Regulation (EU)
528/2012) came into force on
1 September 2013 (repealing
the Biocidal Products Directi-
ve (Directive 98/8/EC)). The
BPR concerns the placment
and use of biocidal products
on the market, which are used
to protect humans, animals,
materials or articles against
harmful organisms, like pests
or bacteria through active
substances within the biocidal
product.
In general, all biocidal pro-
ducts require authorization
before they can be placed on
the market, and the active
substances contained in that
biocidal product must be
previously approved. How-
ever, there are certain excepti-
ons and transitional periods
for certain provisions. For
example, active substances in
the Review Programme
(where the final decision on
approval is still pending) can
be made available on the mar-
ket as ingredient in biocidal
products. Products contai-
ning new active substances
that are still under assessment
may also be allowed on the
market if provisional authori-
sation is granted.
Applications for active sub-
stances or biocidal products
are done on the IT tool IU-
CLID 5 (International Uni-
form Chemical Information
Database). The application
dossiers will be submitted to
ECHA via the IT platform
R4BP 3 (Register for Biocidal
Products). This tool is also
used to exchange data and
information between the ap-
plicant, ECHA, Member State
competent authorities and the
European Commission which
grant authorization.
This guide is meant to intro-
duce the interested party to
the processes involved in a
biocidal product application.
It is important to note that
biocidal products typically
takes at least two years to fully
authorize as there are two
steps primary involved (the
authorization of the active
substances in the product
then the authorization of the
biocidal product). With the
current EU policy requiring
all biocides to be registered by
September 2015, now is the
time to begin the application
process in order to complete-
ly and correctly submit your
application. If your applica-
tion is not submitted in time,
the biocidal product will
have to be pulled from the
market regardless of whether
it is safe or not.
MAY 2015
Introduction
Version 1.0
GeneralGuideforBiocidalAuthorization
ACA-PHARMACONCEPTGMBH
Biocide Definition
Introduction 1
Biocide Definition 1
Active Substance 2
Application Timeline 2
Special Deadlines 2
List of Abreviations 3
SME Status 3
Product Types 4
Authorization Types 5
Nanomaterials 5
In situ Biocides 5
List of Other Guides 6
Useful Links 6
Contact Information 6
Table of Contents
According to Article 3 of BPR,
a biocide is any substance or
mixture, in the form in which
it is supplied to the user, con-
sisting of, containing or gene-
rating one or more active sub-
stances, with the intention of
destroying, deterring, ren-
dering harmless, preventing
the action of, or otherwise
exerting a controlling effect on
any harmful organism by any
means other than mere physi-
cal or mechanical action as
well as any substance or mix-
ture, generated from sub-
stances or mixtures which do
not themselves fall under the
first definition, to be used with
the intention of destroying,
deterring, rendering harmless,
preventing the action of, or
otherwise exerting a control-
ling effect on, any harmful
organism by any means
other than mere physical or
mechanical action.
Often biocides are used to
protect economic products
that could be damaged or
destroyed by a harmful orga-
nism. This includes argicul-
tural products including
food and lumber as well as
animals. Generally speaking,
biocides under this definiti-
on are either pesticides
(including herbicides,
insceticides, and rodentici-
des among others) or anti-
microbials (including antibi-
otics, antifugals, and antipa-
rasites among others) or
both. It is important to no-
te, however, that a product
will only be considered a
biocide if its action does not
fall into the list of regulati-
ons in Article 2 of BPR
which includes biocides that
are present in feed, medica-
ted feedstuffs,veterinary
medicines,human medicines,
flavourings and ingredients
with flavouring properties,
plant protection products,
toys, cosmetics, or biocides
used as processing aids.

2. by ECHA before entering the market.
In situ biocides must submit their dossiers
which include the suppliers of the precur-
sors as well as information on the biocide
produced to ECHA for evaluation by the
1st of September 2015.
Articles treated with biocides must have
submitted their applications by the 1st of
September 2016 unless it contains ative
substances that have not been yet recogn-
zed by ECHA in which case it has until
March 1st 2017.
Biocidal products with SVHCs/candidates
for substitution as active substances or
non-active components must be regis-
tered by September 1st 2015 and since
ECHA is attempting to replace SVHCs,
these products cannot be authorized for
more than five years.
Seite 2 GENERAL GUIDE FOR BIOCIDAL AUTHORIZATION
Application Timeline
Submission
of Application
Validation
For substances currently
on the market, submissi-
on must occur by the:
1st of September 2015
Fee
payment
Requested
information
BPC
decision
30 30 90 365 270 days
Comments
on draft
30Dossier
evaluation
Committee
decision for
authorization
The time for authorization of a biocidal product is approximately two years. The time required for
a dossier evaluation and BPC decision are approximate. The time required for the final committee
decision on authorization is highly variable. Also, should additional information be requested
during the dossier evaluation, an additional 180 days may be given to provide the necessary data.
Biocidal authorization can be granted
for up to 10 years. If the biocidal pro-
duct contains a substance that is up for
substitution, the biocidal product can-
not get granted authorization for more
than 5 years.
If the substance in question is already
under the jurisdiction of a previous
biocidal regulation, it does not have to
follow current ECHA biocidal regulati-
ons. Materials which wish to enter the
European market must be approved
Special Deadlines
Additional
information
180
EU
authorization
Before any biocidal product is approved by ECHA, the active substances that are part of a biocidal function must be ap-
proved and authorized for use in the EU through ECHA.
The first step to do this is to submit a IUCLID active substance portfolio to a member state‘s competenet authority via
R4BP3. After the member state has evaluated the substance, ECHA‘s biocidal comittee will also decide on the status of
the active substance in question within 270 days. [For further information on how to use and submit the required informa-
tion to ECHA for approval, please see ACA-Pharma Concept‘s IUCLID guide to Biocides]
These opinions serve as the basis for the decision on approval which is then adopted by the European Commission. Gai-
ning approval for the active substance can take well over a year, so it is important to start the approval process as soon as
possible. Once approval has been granted, an active substance‘s approval can be granted for up to 10 years and is rewable.
In principle, active substances meeting the exclusion criteria defined in the BPR will not be approved. However, sub-
stances of very high concern, such as those that are carcinogenic, mutagenic and reprotoxic substances in categories 1A
or 1B in CLP Regulation, endocrine disruptors, and substances which are persistent bioaccumulative and toxic (PBT) or
are very persistent and very bioacumulative (vPvB) will not be approved unless there are no alternatives available. If the
substance of high concern is indeed the only option, it can only be approved for up to five years and is subject to evaulati-
on in the case of a better, safer substitute.
Biocidal Products Committee opinions on active substance approval can be viewed on ECHA Homepage. European
Commission includes approved active substances in the Union list of approved active substances (formerly Annex I of
Directive 98/8/EC). Companies wishing to get an authorisation for a biocidal product can consult this list to identify ac-
tive substances for use in biocidal products and treated articles.
A consolidated list of existing active substances for which a decision of non-inclusion into Annex I or IA of Directive
98/8/EC has been adopted is also available. Biocidal products containing active substances for which a non-inclusion
decision was taken shall be removed from the market within 12 months of the entering into force of such decision; unless
otherwise stipulated in that non-inclusion decision.
Active Substance Authorization

3. List of Abbreviations
Abbreviation Complete name Explanation
BPC Biocidal product committee The committe under ECHA which ultimately decides the fate of a dossier‘s applicaiton (whether
or not is should be authorized)
BPR Biocidal product regiulation Regulation EC 528/2012 that governs the use, productions, and distribution of biocides in the
EU which companies are obligated to follow
CLP Classification, labelling and packaging
regulation
Regulation EC 1272/2008 that harmonizes the criteria for classification and the rules on label-
ling and packaging harardous goods and mixtures
ECHA European Chemicals Agency Regulatory authority on chemical safety which is also responsible for the impelentation of EU
chemical regulations
EU European Union International governing body which allows for trade and economic regualtions to be the same
throughout member states
IUCLID International Uniform Chemical
Information Database
IT tool used for data submission, evaluation and exchange
PBT Persistent bioaccumulative and toxic A variety of toxic chemicals that exhibit persistent bioacculumative properties that are consi-
dered SVHCs by ECHA
REACH Registration, evaluation, authorization ,
and restriction of chemicals
Regulation EG 1907/2006 which stipulates the registration, evaluation, authorization, and
restriction processes and rules for chemicals in the EU
SME Micro-, small, and medium-sized enter-
prises
Enterprises that are defined according to their staff head count and turnover or annual balan-
ce-sheet total. Thez can recieve discounted fees and charges during ECHA registration once
their SME status is confirmed
SVHC Substance of very high concern Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for repro-
duction category 1A or 1B or which are PBT or vPvB or giving rise to an equivalent level of
concern. They may need to be authorised for specific uses but must follow stricter guidelines
as approved by ECHA
vPvB Very persistent and very bioaccumulati-
ve
A variety of chemicals that are very bioacculumative and persist in the environment for pro-
longed periods of time that are considered SVHCs by ECHA
Seite 3MAY 2015
SME Status
SMEs (micro-,small, and medium enter-
prises) are elligible for reduced fees and
charges during ECHA registration. As
such, SME registration is highly moni-
tored and mistakes within the applicati-
on for SME status can result in steep
fine and charges.
The information needed to prove SME
status is simple: staff head count and
annual turnover/balance sheet totals.
Of these two factors, staff head count is
the more important of the two and will
often decide the exact status of the
enterprise. Staff, in this case, applies to
employees (actual or recognized as usch
under national law), owner-managers,
persons working for the enterprise and
being subordinated to it, as well as part-
ners who are engaged in the company and
recieve financial benefits from it. It does
not include apprentices or students enga-
ged in vocational training. Maternity and
paternity leaves are also not included.
Microenterprises should have a staff of
less than 10 individuals. Small enterprises
should have less than 50 staf members
while medium enterprises should have less
than 250. If the staff number falls below a
threshold, the annual turnover/annual
balanace sheet total for the past two years
will be used to determine placement.
Microenterprises should have an annual
turnover less than 2 million euros while a
small enterprise and a medium enterprise
should have annual turnovers of less than
10 million euros and 43 million euros
respectively.
It is important to note that if the enter-
prise in question is not autonomous (fully
independent or lesss than 25% of its ca-
pital or holding rights are held by outside
investors) all of its linked or partner
enterprises must be included in the deter-
mination of SME status.

4. Seite 4 GENERAL GUIDE FOR BIOCIDAL AUTHORIZATION
Product Types
Main Group Type
number
Product-type Description
Disinfectants 1 Human hygiene products Skin or scalp disinfectants
Disinfectants 2 Disinfectants/algaecides not for dirrect
applications to humans or animals
Surface disinfectants, water disinfecants that are not intended for animal or human
ingestion, air disiinfectants, and other products with disinfecting properties...
Disinfectants 3 Veterinary hygiene Surface disinfectants and anti-microbials for the housing of animals...
Disinfectants 4 Food and feed area Disinfectants for equipment, containers, utensils, surfaces, or pipework associated
with production, storage, transport, or consumption of food and feed including water
Disinfectants 5 Drinking water disinfectants For animals and human use
Preservatives 6 Preservatives for products during
storage
Preservation of manufactured products other than foodtuffs, feedingstuffs, cometics,
or medical products and storage or use of rodenticide, insecticide, or other baits
Preservatives 7 Film preservatives Preservation of paints, plastics, selanats, sealants, binders, papers, art work, and wall
adhesives
Preservatives 8 Wood preservatives Preventative and curative products from and including the saw-mill stage
Preservatives 9 Fiber, leather, rubber, and polymerized
material preservatives
Materials which prevent microbial settling and deterioration
Preservatives 10 Construction material preservatives Preservation of masonry, composiste materials and other non-wood materials
Preservatives 11 Preservatives for liquid-cooling an
dprocessing systems
Preservation of water and other liquids by controlling organisms
Preservatives 12 Slimicides Prevention/control of slime on materials, equipment and structures in industrial pro-
cesses
Preservatives 13 Working or cutting fluid preservatives Control microbial deteioration in fluids used for working or cutting metals, glass, or
other materials
Pesticides 14 Rodenticides By means other than repulsion or attraction
Pesticides 15 Avicides By means other than repulsion or attraction
Pesticides 16 Molluscicides vermicides, and products
used to control other invertebrates
By means other than repulsion or attraction
Pesticides 17 Piscicides By means other than repulsion or attraction
Pesticides 18 Insceticides, acaracides, and products
to control other arthropods
By means other than repulsion or attraction
Pesticides 19 Repellents and attractants By repelling or attracting harmful organisms (including fleas, vertebrates such as
birds, fish and rodents) in question on a surface or on human or animal skin
Pesticides 20 Control of other vertebrates Other methods of control other than attraction or repulsion of vertebrates other than
those before
Other Biocidal
Product
21 Antifouling products Limit the settling of microbes and higher organisms on vessels, aquaculture or other
structures in water
Other Biocidal
Product
22 Embalming or taxidermist fluids Disinfection and preservation of human and animal corpses

5. Authorization Types
Seite 5MAY 2015
ECHA provides several kinds of authorization types for biocidal products The determination of which authorization is given de-
pends on the product in question as well as the markets(s) in which the company wants to sell its product in.
National authorization
National authorization is for companies that want their product to be authorized in one EU member state. The application
must be submitted via R4BP 3. The member state‘s competent authority will then process the authorization request analyze
and compare the substance to other substances which may be less harmful, and make a decision on authorization within
365 days.
Mutual recognition
Mutual recognition is national authorization that has been recognized beyong the frist/reference country of application and
is done when a company requests other EU member states to recognize ist product.This can be done in parallel or sequen-
tially with its application to the reference EU member state. Either way, the dossier must be submitted via R4BP 3 and the
decision on recognition will take approximately five months after authorization has been granted in the reference EU mem-
ber state. If recognition is not agreed upon, the case will be referred to the Commission and if the Commission cannot agree
the case will be referred to ECHA.
Union authorization
Union authorization can be granted to certain substances which have similar conditions of use across the EU. Though there
are exclusion criteria for the products (also, product-types 14, 15, 17, 20, and 21 are excluded), the products granted Union
authorization, do not have to seek EU member state recognition. If a product has both new and existing active substances,
it can currently be registered for EU authorization. If, however, it only has existing substances its authorization time de-
pends on the product-type. Product-types 1, 3, 4, 5, 18 and 19 can be registered from September 1st 2013 while product-
types 2, 6 and 13 can begin registration from January 1st 2017. Product-types 7, 8, 9, 10, 11, 12, 16 and 22 can only register
for Union authorization after January 1st 2020.
Simplified authorization
If the biocidal product‘s active substances are all in Annex I and comply with specified restrictions and if the biocidal pro-
duct does not contain SVHCs or nanomaterials, if its handling and use doesn‘t require personal protective equipment, and
is sufficiently efficient, it can apply for simplified authorization as it is not a very harmful biocide that requires much regula-
tion. To gain authorization, the company must submit its application to an EU member state via R4BP 3. Once the authori-
zation is granted, the company does not have to apply for mutual recognition prior to putting its product on other EU
member states markets. However, it must notify each EU member state 30 days before entering the EU market via R4BP3.
Renewal
For renewal of authorization and recognition, applications must be sent to all EU member states (involved 550 days before
expiry of authorization and recognition. In the case that the company has forgotten to apply for renewal, the company has
180 days to remove its product from the market.
Nanomaterials
Nanomaterials are defined by ECHA as
materials in which 50% or more of the
particles are 1-100nm in at least one
direction. They can be present as free,
unbound particles as well as in aggrega-
tes and agglomerates.
In biocidal products, the presence of
nanomaterials must be made clear
„nano“ in brackets present in the dossier
materials list.
All products containing nanomaterials
are excluded from the simplified authori-
zation procedure and authorization of
products with nanomaterials will last 5
years.
(regardless of whether or not the nano-
material is an active substance or not). It
is important to note that, unless explicitly
stated, the nanoform of a active substance
is not approved. A seperate dossier must
then be prepared for most nanomaterials.
In a biocidal product, all nanomaterials
must have the material name followed by
For in situ biocides, the active sub-
stances created during the process as
well as the associated precursors will
be considered prior to the acceptance
of the biocide on the market. As
such, the precursors and the resulting
active substance must all apply for
registration as separate substances
(which then have to be registered all
together within the resulting biocidal
product noting that the active sub-
stance is in situ). The precursors may
not need to be registered in the case
that the active substance is produced
from their mixture yet they are chemi-
cally stable.
In situ Biocides
The resulting registered in situ biocides
(including releasing substances as well as
the active substance released) will be placed
into Article 95 to provide a centralized da-
tabase.
In situ biocidal product regulation lasts up
to 10 years for the active substance regis-
tered.

6.  IUCLID Manual for
Biocides
 CLP Manual for
Biocides
Other Guides
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Telefon: +49 341 33 73 33 60
Fax: +49 341 33 73 33 69
E-Mail: aca24@aca-pharma.de
Useful Links
ACA-Pharma Concept GmbH/Biocides
[http://aca-pharma.de/chemicals-biocides/]
ECHA/Biocidal Products Regulation
[http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02012R0528-
20140425&from=EN]
ECHA/Application of CLP regulation
[http://echa.europa.eu/documents/10162/13562/clp_en.pdf]
ECHA/Data sharing
[http://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_en.pdf]