Biocides White Paper

UK HEALTH, ENVIRONMENTAL & REGULATORY SERVICES
THE EU BIOCIDES PRODUCT

REGULATION 528/2012
Author: Lola Akintoye
Senior Toxicologist
White Paper
THE EU BIOCIDES PRODUCT REGULATION 528/2012
CONTENTS
Summary 4
1.0 Background 5
2.0 Scope of the BPR 6

2.1 Definition of Biocides 6
2.2 Biocidal Product or Treated Article? 7
3.0 Overview of the Key Changes: BPD to BPR 8

3.1 Product Authorisation 8
3.2 Widening of the Scope 10
3.3 New Hazard-Based “Cut-Off Criteria” 11
3.4 Article 95: List of (Alternative) Suppliers of Active Substances 11
3.5 Mandatory Data Sharing, Data Compensation and Data Protection 11
4.0 What Are My Obligations under BPR 13
intertek.com/biocides 3
SUMMARY
In 2012, in order to streamline and improve the evaluation and authorisation process for
biocidal products entering the EU market, the European Parliament adopted Regulation (EU)
No 528/2012 concerning the availability and use of biocidal products making available on
the EU market and use of biocidal products (commonly referred to as the “BP Regulation” or
“BPR”). Biocides are widely used industrially and domestically and include insect repellents,
disinfectants, water purification products, rodenticides, anti-mould sprays, and many material
preservatives. As a direct consequence of their intended function to disrupt biological
organisms, these chemicals can pose risks to humans, animals, and the environment.
The BPR harmonises rules on making biocidal products available on the market and
their use through outlining criteria for:
• Establishing a list of approved active substances which may be used in biocidal products in
Europe;
• The authorisation of biocidal products and mutual recognition of authorisation within the
Member States in the EU;
• Placing on the market of treated articles; and,
• New simplified authorisation procedures (Annex I, parallel trade permit, same products
authorisation, etc.).
By replacing the directive with the Regulation, which is directly transposed into national law
and binding in its entirety and enforced simultaneously, the BPR provides greater uniformity
of risk controls throughout the Union.
1.0 BACKGROUND
The regulation that has been applicable since 1st September 2013 repealed and replaced
the Biocidal Products Directive 98/8/EC (known as the “Biocides Directive” or BPD). The
BPD enacted in 1998 set the foundation for ensuring a high level of public health and
environmental protection by introducing a harmonised regulatory framework for biocidal
products across the EU. Under the BPD, 23 product types were defined and a two-stage
process for authorisation of biocidal products was established; first the EU-level approval of
an active biocidal substances for use in a particular field of application (‘product type’) and
secondly, Member States (MS) authorisation of a specific biocidal product containing the
approved active substance(s).
The system that was administered by national authorities included a review programme to
evaluate all biocidal active substances that were already present on the EU market before
May 14th 2000 (i.e. ‘existing active substances’) to ensure these could continue to be used
in formulated biocidal products without posing unacceptable risks to humans, animals or the
environment. This review programme was controlled by a series of Regulations that amongst
other things set the deadlines for dossiers to be submitted to the rapporteur Competent
Authority by persons supporting the continued use of any particular active. Active(s) and
products supported within the biocides review programme were permitted to be marketed
until a decision is made on their acceptability for use. In the meantime, these substance/
product types are subject to national legislation. Once the review of a particular substance is
completed, the EU issues a decision whether to include it in the positive list (i.e. Annex 1 or 1A
of the BPD). Actives and end-use products not meeting the required criteria for inclusion on
the positive list must be withdrawn from or not placed on the EU market by the date stated
in the non-inclusion decision. The MS may then authorise products containing the active
substance for the applicable product type(s) for which it has been included onto Annex 1/1A
provided the necessary data requirements and conditions of inclusion in the annex have been
fulfilled.
The previous evaluation process was cumbersome, slow and very costly for the industry
particularly small and medium enterprises (SME). This meant that many existing biocidal
actives were not supported and had to be withdrawn from the market, and few new actives
were developed. Furthermore there were other weaknesses with the BPD including limited
scope, data protection was not guaranteed and inconsistency in the compliance fees
charged by different MS. In addition, there was a loophole in the BPD which allowed products
manufactured outside of the EU to include biocides which were not permitted for use in
the EU. Following several reviews of its implementation and operation, a major revision of
the Directive was proposed, which culminated in a proposal for a Regulation published by
the EU Commission on 12 June 2009 (COM(2009)267. The text of the Regulation (now
known as BPR) was finalized in November 2011 and adopted by the Council of Europe
on 10th May 2012. The BPR effectively extends the deadline for the approval of existing
active substances as well as the formulated products. The review programme is targeted for
completion by 2024. Meanwhile, new active substances have to go through an even more
rigorous authorisation procedure as outlined in the BPR.
2.0 SCOPE OF THE BPR
Regulation (EU) 528/2012 applies to biocidal products, articles or materials treated

with biocidal products (including textiles, furniture). It also applies to active substances
generated in situ (whether from supplied precursors and where no precursor is supplied e.g.
sodium hypochlorite generated from sea water), and nanomaterials (which are regulated
separately from the non-nano form). Biocidal products are now split into 22 product types
which are broadly categorised under four main groups – disinfectants, preservatives, pest
control and other biocidal products. In the incoming Regulation, some product types will be
changed or expanded and, product type 20 (preservatives for food and feedstock) will be
removed as such preservatives are regulated by other EU legislation.
Products that are not for dual use and regulated under another piece of EU legislation such
as medicinal products for human and veterinary use, food or feed, medical devices, cosmetic
products and in-can preservatives for cosmetics products, plant protection products and toys
(however as with other treated articles the toy may require labelling) are outside the scope of
the BPR. It is noteworthy that biocidal products and treated articles falling within the scope of
these other EU instruments but intended to be used for purposes other than those covered
therein would be regulated under the BPR. Dual use products such as a product marketed
as a sunscreen and repellent may potentially be regulated via Cosmetics Regulation for its
sunscreen function and via BPR for its repellent action.
2.1 Definition of Biocide

A biocide or biocidal product is defined as “any substance or a mixture, including ‘in-situ’
generated active substances and mixtures, in the form in which it is supplied to the user,
consisting of, containing or generating one or more active substances, with the intention
of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting
a controlling effect on, any harmful organism by any means other than mere physical or
mechanical action”. In addition, the biocidal product definition covers situations where a
substance or a mixture, generated from a substance or mixture not covered by the first
intent is used with the purpose of destroying deterring, rendering harmless, preventing the
action of, or otherwise exerting a controlling effect on, any harmful organism by any means
other than mere physical or mechanical action.
A biocidal active is a substance or a micro-organism that has an action on or against harmful

organisms i.e. organisms, including pathogenic agents, which has an unwanted presence or a
detrimental effect on humans, their activities or the products they use on produce, on animals
or the environment. Biocidal active substance may either be “existing” or “new”. An existing
active substance is one which was available on the market in biocidal products prior to or
on May 14, 2000 and which is under evaluation in the review programme for existing active
substances used in biocidal products. A new active is a substance that was made available
on the market in biocidal products only after May 14, 2000 or was not included in the review
programme. An active substance is regarded as ‘existing’ only for the product-type(s) for
which it is being evaluated in the review programme, but will be regarded as new for the
product-types which are not included in the review programme.
‘Biocidal product family’ is a new concept introduced under the BPR and is defined as “a group
of biocidal products having similar uses, same active substances of 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”. Variations in composition may
relate to the percentage of one or more active substances and/or non-active substances or
the replacement of one or more non-active substances by other ingredients presenting the
same or lower risk. This concept has a broader application than the BPD Frame Formulation.
2.2 Biocidal Product or Treated Article?

The BPR introduces the concept of treated articles, which are defined as “any substance,
mixture or article which has been treated with, or intentionally incorporates, one or more
biocidal products”. It should be noted that this differs from the concept of treated articles
under the REACH Regulation. Treated articles are categorised in three ways and the specific
obligations applicable under the BPR depend on the claims made on such products.
A treated article that bears a claim of ‘primary biocidal function’ is considered to be a biocidal
product and will require authorisation prior to being placed on the EU market. This function
is not intended to protect the article itself, but to provide biocidal activity during its use.
Examples include mosquito nets treated with insect repellent or insecticides with the aim of
controlling mosquitoes as well as computer keyboards treated with an antimicrobial to prevent
bacterial growth.
The second class of treated articles would be products making a claim relating to its biocidal
properties; wherein the article has been treated with or intentionally incorporates a biocidal
product with a view to protect its properties or function, or extend its durability or shelf life.
These products need no authorisation but will require specific labelling. Examples of such
treated articles include odourless socks treated with or incorporating antimicrobial agent, and
furniture treated with wood preservatives.
A third class of treated articles are products that are simply preserved with a biocidal product
but for which no claims of a biocidal function are made. In this case, as long as the active
substance does not trigger the labelling requirement, no specific labelling would be required.
Examples include: impregnated chopping boards, underwear, preservatives for paint, etc.
Some categories of treated articles have two or more functions, one of which is biocidal;
e.g. clothing treated with insect repellent has the function of covering the body as well as
an action against insects. This clothing item may either be categorised as biocidal product
or treated article depending on whether the biocidal function (insect repellent) is primary or
secondary. The term “primary biocidal function” can in this context be interpreted as a biocidal
function of first rank, importance, or value compared to other functions. Thus, treated article
with primary biocidal function refers to an article (as defined under BPR) that has one or more
functions, of which one is biocidal function of first rank, importance, or value compared to its
other functions. The following criteria, though not exhaustive, may be applied in categorising
a treated article that has a primary biocidal function:
• The target species, in particular when the species would not be harmful to the treated
articles itself;
• The concentration of the active substance(s) in the treated article especially if comparable
to that in an existing biocidal product;
• The mode of action of the active substance(s) or the treated article;
• The intended use and purpose of the treated article; and/or,
• Claims made regarding the function of the treated article, in particular when it would be
identical to that of an existing biocidal product.
3.0 OVERVIEW OF THE KEY

CHANGES: BPD TO BPR
As under the previous Biocidal Products Directive, active substances shall be evaluated at
EU level for use in biocidal products and be approved in different product types. In addition,
the general obligations concerning data requirements for applications and the transitional
measures for a biocidal product during its active substance review remain the same.
However, there are key changes to the product authorisation, the scope, data protection and
administrative procedures that stakeholders in the biocide industry must be aware of in order
to ensure full compliance to the BPR.
As detailed above (section 2.0), there are now 22 product types rather than 23 under four
main groups. The active substances still need to be approved for use in biocidal products
placed on the EU market. These approved actives are regulated under the BPR on a Union list
of active substances that is be published and updated by ECHA. Annex 1 and 1A as defined
under BPD no longer exists; however, all active substances previously included in these
Annexes are deemed to be included on the Union list. In addition, the BPR includes an Annex
1, which is a list of active substances that can be used in biocidal product(s) that qualify for a
simplified authorisation procedure (discussed below).
3.1 Product Authorisation

A biocidal product/biocidal family must be authorised to be placed on the market. Previously
(under the BPD), biocidal products are approved by applying in one MS and then getting
mutual recognition in another. The BPR includes a few more routes for authorisation; the
provision of “union authorisation” is perhaps the most significant. Union authorisation allows
for a single authorisation to be obtained for certain biocidal products that would be valid
in the whole of the EU without the need for mutual recognition or separate approval from
individual MS.
Although the concept of ‘union authorisation’ appears to be an ideal route for companies
intending to sell biocides throughout the EU , there are criteria which must be fulfilled for a
product to be considered. The product for Union authorisation must have similar conditions
of use across the EU and must not include active substance(s) that are considered to be
particularly hazardous (as defined in Art. 5 of BPR). Furthermore, it does not apply to all active
substances or all product types and a phased implementation of the process is applied. Union-
wide authorisation is not possible for biocides to control animals such as birds, fish, and rats,
or anti-foulant products. Thus, product types 14, 15, 17, 20 and 21 are excluded entirely. For
the other product types, the possibility to apply for Union authorisation is introduced step-
wise. The first phase-in from September 1st 2013 allows for product types 1, 3, 4, 5, 18, and
19. For product types 2, 6, and 13, the possibility of Union authorisation becomes applicable
as of January 1, 2017 and on January 1, 2020, the remaining product types (i.e. 7, 8, 9, 10,
11, 16, and 22) can be registered under the Union authorisation scheme. Hence, it has been
possible to obtain an EU-wide authorisation through application to ECHA for products such
as disinfectants for hand hygiene (PT1), veterinary hygiene (PT3), food and feed area (PT4),
water purification (PT 5), insecticides and repellents since September 1, 2013. Furthermore,
as of January 1, 2017, other disinfectants for home and hospital use may proceed through
Union authorisation.
National authorisation as it was under the old directive remains available. An application for
approval of a biocidal product may be submitted to the Competent Authority in any one MS.
The timelines for MS are more clearly defined under the BPR e.g. evaluation of the product
must be conducted within 365 days of application. During this time, the applicant cannot
apply concurrently to the competent authorities in other MS for national authorisation of
the same product for the same use. However, it is possible to apply for mutual recognition in
parallel.
Mutual authorisation of a biocidal product may either be applied for in sequence or in parallel
to the national one. Mutual recognition in parallel is a process whereby an applicant can
apply simultaneously for the first authorisation of its biocidal product in a MS and mutual
recognition in the other EU countries. The initial authorising country and the ‘MS concerned
(CMSs)’ (i.e. other EU countries where a national authorisation is sought), must agree on
the summary of biocidal products characteristics (SPC) before the product is authorised
in their country. In case of a disagreement by one or more of the member states, the rest
can authorise the product whilst discussions on resolving the differences take place at the
coordination group and ultimately, the Commission.
This is different to the process under the BPD where the initial authorising country can grant
the authorisation before the mutual recognitions are granted. Akin to the process under
the BPD, mutual recognition in sequence is used when a biocidal product has already been
granted national authorisation in one (or more) MS and the applicant intends to apply for
approval to sell in other EU countries. For instance, if a product that has been granted national
authorisation in France and the manufacturer or formulator intends to enter the marketing
the UK, Ireland and Italy; they can apply to these MS for mutual recognition in sequence.
Each CMS shall agree on the SPC and authorise after all CMS are in agreement. In the event
of a dispute, the CMS that are not involved in the disagreement may authorise the product
whilst the discussion to resolve the dispute is on-going at the co-ordination group or the
Commission. It is important to note that for existing biocidal products only applications for
mutual recognition in parallel, not in sequence, will benefit from the transitional provisions
which allow the product to stay on the market whilst the authorisation is being carried out.
A simplified authorisation procedure aiming to encourage the use of biocidal products

that are lower risk to the environment, human, and animal health has been initiated under
the BPR. Only biocidal product(s) containing active substance(s) listed on Annex 1 of BPR
(‘low risk compound’), no substance of concern or nanomaterial in the formulation and has
been demonstrated to be effective with no personal protective equipment (PPE) required
for handling or the intended use, may be considered for simplified authorisation procedure.
The application is made to ECHA and is evaluated by nominated MS competent authority
within 90 days. Where a simplified authorisation is granted, the biocidal product may be
made available on the market in all Member States without the need for mutual recognition.
However, the authorisation holder is required to notify the relevant MS 30 days before placing
the product on their market. The categories of compounds eligible for inclusion on Annex
1 of BPR are limited to substances identified as posing low risk under REACH (Annex IV
substances – ascorbic acid, linseed oil), or BPD (on Annex 1 / 1A - carbon dioxide, nitrogen etc.),
substances identified as food additives (e.g. lactic acid, sodium acetate, tartaric acid, acetic
acid), pheromones and other substances considered to have low toxicity, such as weak acids,
alcohols and vegetable oils used in cosmetics and food.
Other types of authorisation available for biocidal products under the BPR include parallel
trade permit, which allows a product to be imported and placed on the market in one MS (i.e.
Member State of introduction) if it is already authorised in another MS under the EU BPR and,
there is an identical biocidal product already authorised in the Member State of introduction.
Furthermore, a provision exists wherein a research permit may be granted, which allows a
biocidal product on the market for the purposes of research and development.
3.2 Widening of the Scope

Certain products that are regulated under other pieces of legislation have been removed
from the scope. These products include food and feed additives, as well as processing aids.
Rules have been introduced for in-situ generated biocidal products, which under the BPD
were poorly regulated. Nano-forms of an active substance are considered as separate active
substance from their non-nano counterparts. Thus, the review of an existing active substance
will only cover nano-form if data has been submitted on those specific nanomaterials. Some
of the product types have been expanded or changed with products such as vermicides
(worm killers) and other biocides for use on invertebrates not originally covered by the BPD
now included for product type 16. In addition, working or cutting fluid preservatives are now
captured in product type 13.
The biocides used in treated articles are specifically covered by the BPR. No treated article
may be placed on the market unless all of the active substances contained in the biocidal
products with which it was treated, or incorporated, are approved in accordance with the
BPR. Active substance approval must cover both the product type (PT) and intended use.
Additionally, the conditions and restrictions specified in the approval for use of the active(s) in
the biocidal product that is present in the treated articles must be met. There are transitional
measures applicable to existing treated articles (i.e. those available on the EU market on
September 1st, 2013) that contain active substances that have not been approved for that
use or are not currently considered under the review programme. Under these measures, the
existing treated articles could remain on the market until September 1st 2016 or, if under
the review programme, until such time that a decision is taken on the approval of the active
substance(s). Thus, an application must have been be made to ECHA by this date (September
1st. 2016) for existing treated article to extend the active substance approval or it must be
removed from the market by March 1st, 2017. For biocidal products that are newly captured
in scope (i.e. not within the scope under the BPD), the application deadline is September 1st,
2017.
Existing treated articles containing an existing active substance for which a non-inclusion
decision on the relevant PT is made must be withdrawn from the EU market 180 days after
the decision or on September 1st, 2016, whichever is the later. New treated article (i.e. articles
placed on the EU market after September 1st, 2013) can only be placed on the market if they
contain an active substance approved for use in that product type and, for those employing
new active substances, only after the approval.
Dependent up on the function of the biocides, labelling requirements are now applicable for
treated articles. Labelling of a treated article is required if a claim is made by the manufacturer
regarding its biocidal properties, e.g. refrigerators with silver impregnated liners. Furthermore,
if there is a possibility of the active substance(s) contacting humans or being released to the
environment, e.g. treated textiles such as odour reducing socks, labelling requirements exist.
The treated article labelling requirements of the BPR do not fall under derogation and are
applicable as of September 1st, 2013. The information on the label should be provided in the
national language(s), clearly visible, legible, durable, and must include:
• Statement that the treated article contains a biocidal product;
• Names of active substance(s) and any nanomaterial(s);
• Substantiated biocidal properties of the article; and,
• Relevant instructions for use to protect humans and the environment.
The downstream user of a treated article has the right under the BPR to information on the
biocidal treatment of such product. Thus BPR makes it obligatory for the supplier of treated
article e.g. shop, wholesaler, distributor etc. to respond to customer requests for information
within 45 days, free of charge.
3.3 New Hazard-Based “Cut-Off Criteria”

Substances with certain properties shall not be approved as active substances. This applies to
substances that are carcinogenic, mutagenic, or known reproductive toxicants. Derogations
can be made when there are no sufficient alternatives and the substance is important for
preventing threats to human health, animal health or the environment. Substances that
are approved according to the derogations become “candidates for substitution”. During
evaluation for authorisation of products containing such substances, a special assessment
should be made if the substances can be replaced with less hazardous substances or with
other methods of pest control.
3.4 Article 95: List of (Alternative) Suppliers of Active Substances

As of September 1st, 2013, the BPR makes it mandatory for any person placing an active
substance on the EU market or in biocidal products to submit to ECHA a dossier, a Letter
of Access (LoA) to a dossier, or reference to a dossier (if protection periods have expired).
Manufacturers or importers that comply with this obligation are included on a list published
by ECHA. As of September 1st, 2015, biocidal products can only be made available (i.e. “any
supply”) on the EU market if either the supplier of the active substance(s) (i.e. manufacturer
or importer) contained in the product or the product supplier is included on the Article 95 list
as an ‘approved source’ for the product-type(s) to which the product belongs. Derogation for
one year (until September 2016) is granted for disposal and use of products not containing
an active from the ‘approved source’ list. There is a provisional but incomplete list on ECHA
website, which includes companies supporting active substances through the review
programme, those that have submitted dossiers on new active substances, and those that
have submitted third party dossiers. It is expected that the Article 95 list would be updated as
alternative suppliers make submissions.
In order to be included on the list as an ‘approved source’, the alternative supplier must contact
the data owner(s) for access; for example, by joining an existing consortium or obtaining a
LoA. In case of prohibitive cost or where an agreement on joining an existing consortium
cannot be agreed; the alternative supplier(s) have the option to develop new dossiers either
as individuals or collectively in an alternative consortium. The new dossier would be subjected
to a compliance check by ECHA and inclusion on the Article 95 list is conditional on a positive
outcome.
The Article 95 List can be accessed at: http://echa.europa.eu/information-on-chemicals/
active-substance-suppliers
3.5 Mandatory Data Sharing, Data Compensation and Data Protection

Considering that one of the aims of the BPR is Considering that one of the aims of the BPR
is to minimise testing on animals and to reduce the monopolistic situation with suppliers of
active substances, mandatory data sharing and compensation for data are incorporated into
the Regulation. Owners of data are obligated to share data with other prospective applicant
(suppliers) with the provision to seek compensation for the cost in a fair, transparent and
non-discriminatory manner. The data are not limited to tests involving vertebrates alone but
to all toxicological and eco-toxicology studies, including any not involving tests on animals. For
active substances in the review programme, it is also extended to include environmental fate
and behaviour studies whether or not it involves tests conducted on vertebrates.
Therefore, BPR requires any person “who intends to perform tests or studies” to determine
which studies have been reviewed during an application made to ECHA before by submitting
an inquiry through R4BP (Register for Biocidal Products). The contact details of the
corresponding data submitters will be provided to the prospective applicant by ECHA. If the
data is protected, the prospective applicant must enter into a negotiation with the data owner
for access to the information; once an adequate but fair compensation has been agreed upon,
the data owner must grant the request.
In case of non-agreement by both parties, the applicant may inform ECHA at the earliest,
one month after the commencement of the discussion of a failure to agree. ECHA can act
within 60 days after negotiations fail to give access to the data provided that the prospective
applicant demonstrates that “every effort has been made to reach an agreement and has paid
the data owner a share of costs incurred”.
Data protection for existing substances in the review programme expires on December 31st,
2025 at the latest.
ECHA plays a central role in applying the Regulation, administering the work programme for
the review of existing actives, and handling applications for Union authorisation including
submissions made to determine technical equivalence between an existing and incoming
product. The main tools for applying for active substance approval or product authorisation
are IUCLID and R4BP.The R4BP is accessible via the ECHA website and is the central hub
through which all biocides applications are submitted and acts as the portal for exchange
of information between applicants, the authorities in the Member States, ECHA and the EU
Commission.
4.0 WHAT ARE MY

OBLIGATIONS UNDER BPR
The BPR applies to manufacturers/importers or suppliers of disinfectants, preservatives,
insecticides, rodenticides or other products designed to control harmful micro-organisms and
manufacturers of treated articles. The respective duties are clearly outlined. MEET OUR EXPERT
Manufacturers/importers (M/I) of biocidal active substances must be included on Article LOLA AKINTOYE;
95 list to be able to supply on the EU market. It is important to note that applications for MSC (TOXICOLOGY),
inclusion in the Article 95 list can only be made by a person established within the EU. MRSB, PGDIP. OCC.
However, for the purpose of Article 95, non-EU manufacturers/suppliers can be represented HYGIENE
by an EU representative, and be indicated on the list next to their EU representative. EUROTOX
REGISTERED
Manufacturer/importers of biocidal product must check to ensure that the supplier/s of the
TOXICOLOGIST
active substance is/are on the approved list for their PT. If all the active substances in the
product are already approved, M/I would need to apply for authorisation (National or Union); Lola Akintoye is a UK and EUROTOX
otherwise, the transitional measures (i.e. national rules which vary from one MS to the other) registered trained toxicologist
would apply. and specialist in chemicals risk
A distributor of a biocidal active substance must ensure that the supplier(s) is listed assessment. Having worked for
on Article 95 for the product-type. The distributor of biocidal product needs to obtain several years on various regulatory
authorisation (National or Union) if the active substance(s) in the formulation is/are approved programmes at the Unit (Chemicals
or alternatively, the M/I apply for the authorisation. If all the active substances are yet to be Regulation Directorate) of the
approved, the national rules of the MS in which the product would be placed on the market UK Health and Safety Executive
apply. This varies between Member States and may involve registration and submission of (HSE) whose primary aim is to
dossiers including data on efficacy, toxicology and environmental fate etc. ensure the safe use of biocides,
industrial chemicals, and pesticides
The requirements of Article 95 Listing and authorisation are not applicable to the producer to protect the health of people and
or importer of treated articles. However, it must be ensured that the biocides in the treated the environment; Lola has a strong
article(s) are approved or under review for that specific product-type. The producers/importers background in safety evaluation
have until September 1st, 2016 to submit dossier if the active substance(s) is not approved or including consumer exposure and
under review for product-type. risk assessment. Lola has evaluated
human health hazards, prepared
the risk assessment reports and
regulatory documents for a number of
biocidal actives and products as well
as high volume industrial chemicals.
Furthermore, she has played
representational roles in scientific
working groups such as the UK
Working Group on Action to Control
Chemicals (WATCH), has been a
participant at many workshops on risk
assessment methodologies and also,
been involved in developing technical
guidance documents.
She is currently the Senior

Toxicologist in the Intertek Toxicology
group based at Leicester and is one
of Intertek’s global experts in biocidal
products safety assessment and
regulation.
REFERENCES
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May
2012 concerning the making available on the market and use of biocidal products (http://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02012R0528-20140425&from=EN).
European Commission Note for Guidance - Frequently asked questions on treated articles.
CA-Sept13-Doc.5.1.e. (Revision 1, December 2014).
ECHA Guidance on the Biocidal Products Regulation. Volume V, Guidance on active
substances and suppliers (Article 95 list). Version 2.0; December 2014 (http://echa.europa.eu/
documents/10162/15623299/biocides_guidance_active_substance_suppliers_en.pdf).
ECHA Practical Guide on Biocidal Products Regulation. ECHA-14-B-19-EN; September 2014.
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UK HEALTH, ENVIRONMENTAL & REGULATORY SERVICES

THE EU BIOCIDES PRODUCT

2.0 Scope of the BPR 6

3.0 Overview of the Key Changes: BPD to BPR 8

4.0 What Are My Obligations under BPR 13

2.0 SCOPE OF THE BPR

Regulation (EU) 528/2012 applies to biocidal products, articles or materials treated

2.1 Definition of Biocide

A biocidal active is a substance or a micro-organism that has an action on or against harmful

2.2 Biocidal Product or Treated Article?

3.0 OVERVIEW OF THE KEY

3.1 Product Authorisation

A simplified authorisation procedure aiming to encourage the use of biocidal products

3.2 Widening of the Scope

3.3 New Hazard-Based “Cut-Off Criteria”

3.4 Article 95: List of (Alternative) Suppliers of Active Substances

3.5 Mandatory Data Sharing, Data Compensation and Data Protection

4.0 WHAT ARE MY

She is currently the Senior

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