Biocides White Paper
Biocides White Paper
Biocides White Paper
White Paper
UK HEALTH, ENVIRONMENTAL & REGULATORY SERVICES
THE EU BIOCIDES PRODUCT REGULATION 528/2012
CONTENTS
Summary 4
1.0 Background 5
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THE EU BIOCIDES PRODUCT REGULATION 528/2012
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.
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THE EU BIOCIDES PRODUCT REGULATION 528/2012
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The regulation that has been applicable since 1st September 2013 repealed and replaced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.
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THE EU BIOCIDES PRODUCT REGULATION 528/2012
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THE EU BIOCIDES PRODUCT REGULATION 528/2012
‘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.
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.
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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).
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.
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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.
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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.
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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.
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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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