CA-May15-Doc.7.4.a
EUROPEAN COMMISSION
EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE
HEALTH AND GENERAL
FOOD SAFETY DIRECTORATE GENERAL
Safety of the food chain
Safety of the food chain
Pesticides and Biocides
Pesticides and Biocides
Note for discussion with Competent Authorities for Biocidal Products
Subject:
Draft Commission report on the sustainable use of biocides
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11
E-mail: [email protected]
Table of Contents
1.
INTRODUCTION ....................................................................................................... 3
1.1. Background........................................................................................................ 3
1.2. Role and importance of biocides – societal demand ......................................... 4
1.3. Objective of the report ....................................................................................... 5
2.
ARTICLE 18 ............................................................................................................... 5
2.1. The promotion of best practices – Article 18 (a) ............................................... 6
2.1.1.
Analysis ............................................................................................... 6
2.1.2.
Conclusion ........................................................................................... 6
2.2. Effective approaches of monitoring the use – Article 18 (b) ............................ 8
2.2.1.
Analysis ............................................................................................... 8
2.2.2.
Conclusion ........................................................................................... 9
2.3. Applicability of IPM – Article 18 (c) .............................................................. 10
2.3.1.
Analysis ............................................................................................. 10
2.3.2.
Conclusion ......................................................................................... 11
2.4. The need for additional measures to reduce risks in specific areas such
as schools, workplaces, kindergartens etc. – Article 18 (d) ............................ 12
2.4.1.
Analysis ............................................................................................. 12
2.4.2.
Conclusion ......................................................................................... 12
2.5. The role of improved performance of equipment - Article 18 (e) ................... 13
3.
2.5.1.
Analysis ............................................................................................. 13
2.5.1.
Conclusion ......................................................................................... 13
TOOLS TO STIMULATE INNOVATION AND PROMOTE
SUSTAINABLE USE ............................................................................................... 14
3.1. The use of an 'eco-label' or other possible schemes ........................................ 14
3.1.1.
Analysis ............................................................................................. 14
3.1.2.
Conclusion ......................................................................................... 14
3.2. Possible amendment of advertising and marketing provisions – Art 72 ......... 15
4.
3.2.1.
Analysis ............................................................................................. 15
3.2.2.
Conclusion ......................................................................................... 15
FINAL CONCLUSIONS .......................................................................................... 16
2
1.
INTRODUCTION
1.1.
Background
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22
May 20121 (hereafter the BPR) regulates the making available on the market and
use of biocidal products. The BPR repealed Directive 98/8/EC and entered into
application on 1 September 2013.
In accordance with Article 3 of the BPR, biocidal products are defined as products
intended to destroy or control harmful or unwanted organisms (such as viruses,
bacteria, fungi, insects and vertebrate animals) that have detrimental effects on
humans, their activities or the products they use or produce, on animals or the
environment. Common examples of such products are, among others, disinfectants,
wood preservatives, insecticides, insect repellents or rodenticides. Biocides are used
in a wide variety of ways to control harmful or unwanted organisms, both by
professional users and the general public.
With regard to biocidal products, the objective of the BPR is to improve the
functioning of the internal market whilst ensuring a high level of environmental and
human health protection.
The BPR establishes that no biocidal product can be placed on the market without
an authorisation granted by a competent authority. This authorisation is only granted
if the evaluation carried out by that competent authority shows that the use of the
product is safe for human and animal health and for the environment. In addition,
the product has to be proven efficacious for the intended uses.
The authorisation scheme of biocidal products is based on a two-step approach:
First, the active substance responsible for the biocidal effect has to be approved at
EU level. Its hazardous properties and possible risks to humans, animals and the
environment are then assessed.
Secondly, every specific product containing that active substance has to be
authorised with regard to its specific formulation (e.g. liquid, spray, etc.), intended
uses (e.g. control of ticks or mosquitos) and user category (e.g. professional users or
general public).
Both processes of active substance approval and product authorisation are initiated
by an application submitted by companies placing the biocidal products on the
market.
With regard to substance approval, in accordance with Article 5(1) of the BPR, the
evaluating competent authority must first check that the active substance does not
meet the exclusion criteria, in which case it would not be approved. The objective of
1
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02012R0528-20140425&from=EN
3
the exclusion criteria is to ensure that the most hazardous active substances like
carcinogens, mutagens and substances toxic for reproduction are phased out. The
evaluating competent authority must also consider whether the active substance is a
candidate for substitution under Article 10 of the BPR. This provision aims at
identifying substances of particular concern to public health or the environment and
to ensure that these substances are phased-out if and when better alternatives are
available.
In a second step, a biocidal product can only be authorised provided that the active
substance has been approved for the relevant product type or is included in the
Annex I. Where a substance has been identified as a candidate for substitution,
biocidal products containing that active substance must be subject to a comparative
assessment at the time of their authorisation. The purpose of this comparative
assessment is to consider whether safer alternative, including non-chemical options,
exists in sufficient numbers and are practical. If this is the case, the biocidal product
shall then not be authorised.
Article 25 of the BPR also encourages the use and placing on the market of products
that are less harmful for the environment, human and animal health. It stipulates the
conditions to be met in order to grant a product authorisation under the simplified
authorisation procedure. Basically a biocidal product is eligible if, amongst other
conditions, it only contains active substances of low concern.
Finally, where deemed necessary when approving a substance and granting an
authorisation, provisions e.g. to limit the use of a product to professional users only,
to prohibit specific types of use or uses in certain areas can be included.
Substance approval, product authorisation, comparative assessment of biocidal
products containing candidates for substitution with the aim of phasing-out their
use, are already first and important steps to promote the use of biocidal products or
of other alternative with a lesser impact on health and environment. As such, they
fully contribute to the objective of sustainable use of biocidal products.
However, it must be noted that most biocidal products are for the time being placed
on the market in accordance with Member States national rules. This provision
applies to biocidal products containing active substances, which were already on the
market in 2000, when the review programme for existing active substances was
initiated and until such time the active substances contained in these biocidal
products are approved. Then, upon approval of the active substance, biocidal
products have to be authorised in accordance with the provisions of the BPR. The
completion date for this review programme, which was initially supposed to be
finished by 2010, was first extended to 2014 and now to 2024. The slower than
anticipated pace of progress of that review programme is therefore a serious
impediment to the more ambitious political objectives fixed by the BPR, such as for
instance efforts to promote the sustainable use of biocidal products.
1.2.
Role and importance of biocides – societal demand
Biocidal products play an important role in EU citizens' daily life. Despite their
properties and the possible risks, the impact of biocidal products on society is
enormous and largely positive. For example, insecticides and disinfectants are
essential for public health to help controlling vector-borne diseases (such as malaria,
dengue fever or chikungunya), food-borne diseases (such as salmonellosis,
4
listeriosis) or hospital-acquired infections such as MRSA. They are also widely used
in materials such as plastics, paints, textiles, wood, etc. to protect these materials
against microbial, fungi or insect decay.
Responding to this societal demand requires considerable investments from
companies placing biocidal products on the market as the data requirements to
demonstrate that a biocidal product is both safe and effective are demanding, and
similar to those requested for a plant protection product. Yet, the size of the biocidal
product market compared to the one on plant protection products is relatively small
(7%) and involves a majority of SMEs.
1.3.
Objective of the report
Article 18 of the BPR stipulates that the Commission shall, on the basis of
experience gained with the application of this Regulation, present to the Council and
the European Parliament a report on how this Regulation contributes to a sustainable
use of biocidal products. This report shall also reflect on the need to introduce
additional measures, in particular for professional users, in view of reducing the risks
posed to human and animal health and the environment by biocidal products.
The same Article lays down some specific elements that need to be examined
(Article. 18(a) to (e)) relating to:
• The promotion of best practices,
• Effective approaches of monitoring the use,
• Applicability of IPM,
• The need for additional measures to reduce risks in specific areas such as
schools, workplaces, kindergartens etc.,
• The role of improved performance of equipment.
The purpose of this report is therefore to examine the elements listed in Article 18 of the
BPR (section 2) but also to propose other elements for reflection (section 3).
This report is based on a study2 carried out by an external contractor on behalf of the
Commission, which involved a large survey of representatives from Member State
Competent Authorities, industry and NGOs (hereafter the survey).
2.
ARTICLE 18
The views and experiences collected during the study provided insight on how
sustainable use of biocidal products can be promoted taking into account the
existing legal framework. This section tries to give an overview of the findings and
provide an answer on whether and how the BPR is contributing to the sustainable
use of biocides.
2
Analysis of measures geared to the sustainable use of biocidal products, by Milieu Ltd 2015
5
2.1.
The promotion of best practices – Article 18 (a)
2.1.1. Analysis
Best practice on the sustainable use of biocides focuses on the use phase of
biocidal products. This means that one should not only concentrate on the
authorisation process as such. A best practice is understood to seek to reduce
risks and to promote technical understanding. From the point of view of
implementation and the applicability (preferably EU wide), involvement of
stakeholders in the development of best practices is desirable.
The survey revealed a wide range of practices, mechanisms or documents
that can be regarded as best practice. In general these can be categorised as
follows:
•
Guidance and other best practice documents.
•
Standards like CEN, ISO standards.
•
Economic incentives, including fee-based approaches.
•
Member State regulatory mechanisms, including binding
standards3.
•
Information mechanisms for the general public or for
professionals and businesses, such as leaflets, web sites from
Member State Competent Authorities, industry associations, NGOs
etc.
2.1.2. Conclusion
A variety of best practice documents relating to different product types do
exist already. A lot of them have been developed by industry or industry
associations. In addition it is noted that some Member States are looking to
develop their own strategies for the sustainable use of biocidal products. For
example, the German Federal Environment Agency issued a position paper4
setting out a ‘Proposal for a concerted European approach towards a
sustainable use’ in December 2014, which also includes a list of possible
actions at the national level.
In order to ensure a harmonised approach to the sustainable use of biocidal
products across the EU, the challenge is to ensure dissemination of best
practice and adherence to the principles of sustainable use of biocidal
products.
3
The main regulatory mechanisms identified, either relate to a number of measures taken by Member
States to prohibit or restrict the use of biocides in specific areas, or to certification schemes, such as in
France ('Certibiocide') or certification schemes which apply to specific product types.
4
6
To that effect compliance with available guidance/best practice
documentation can be made a condition of, or included in the authorisation
of a biocidal product. Consequently, reference can be made to the
guidance/best practice documents on the label and instructions for use of the
product. This option expects the competent authority to stipulate these
requirements within the provisions of the authorisation. The disadvantage
however, is that this relies on the correct application of user instructions by
the end-user.
In case a certification or training scheme is available, reference to such
scheme can be made in the authorisation. For example, this is an approach
being adopted in the UK in relation to the authorisation of rodenticides,
where compliance with a proposed industry stewardship scheme will be
required as a condition of authorisation of anticoagulant rodenticides5. Best
practice guidelines on the safe use of the product, compiled by the industry
body are included in the scheme and the labelling of the product is to contain
the phrase ‘For supply to and use only by professional users holding
certification demonstrating that they have been trained according to the UK
second generation anticoagulant rodenticide (SGAR) stewardship
programme requirements.
Important instruments are the 'Best available techniques reference
documents' (BREFs)6. Particular attention could be paid to the compliance
with best practice on the sustainable use of biocides during the development
and revision of these BREFs. Under Directive 2010/75/EU on industrial
emissions (integrated pollution prevention and control)7 (IPPC) several
BREFs have been developed for different sectors8, some of which covering
the use of biocides in the respective sectors, directly or indirectly:
•
Intensive Rearing of Poultry and Pigs
•
Slaughterhouses and Animals By-products Industries
•
Food, Drink and Milk Industries
•
Surface Treatment using Organic Solvents, which is currently in
review to also cover wood preservation with chemicals
•
Textiles Industry
•
Tanning of Hides and Skins
•
Industrial Cooling Systems
•
Pulp and Paper Industry
5
Second Generation Anticoagulant Rodenticide (SGAR) Stewardship Regime
6
Article 13(1) of the Industrial Emissions Directive (IED, 2010/75/EU)
7
Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial
emissions (integrated pollution prevention and control) (Recast), OJ L 334, 17.12.2010
8
http://eippcb.jrc.ec.europa.eu/reference/
7
•
Emissions from Storage
In this context, BAT (Best available techniques) means the most effective
and advanced stage in the development of activities and their methods of
operation which are economically and technically suitable to prevent or
reduce emissions to the environment. Annex I of the Industrial Emissions
Directive refers to threshold production values in terms of capacities or
outputs of industrial activities covered by the Directive. Installations
operating these activities have to be operated in accordance with a permit
containing conditions based on the application of the Best Available
Techniques (BAT). The BAT conclusions adopted by the European
Commission shall be the reference for the permit conditions, in particular for
the emission limit values which cannot exceed the BAT-associated emission
levels set in the BAT conclusions (unless this is justified on the basis of an
assessment demonstrating that the costs would be disproportionate compared
to the environmental benefits).
In practice, the development or revision of BREFs is carried out by technical
working groups, established by the Commission, with experts from Member
States, industry, and NGOs. The European IPPC Bureau organises the work,
strengthens the exchange of information, makes a scientific and technical
analysis of the data and writes the BREF.
Article 80 of the BPR refers to the 'Fees and Charges' that can be levied by
the European Chemicals Agency (ECHA) and Member States with respect to
the different procedures under the BPR. The Commission ‘Guidance
concerning a Harmonised Structure of Fees’9 suggests that Member States
adapt the level of the annual fees based on, for example, the type of
application or the degree of risk of the product. The lower the degree of risk,
the lower the fee would be. To date in Belgium, all authorisation holders
have to pay, at the beginning of each year, an annual fee, the amount of
which depends on i) the annual quantity of biocide placed on the Belgian
market in the previous year (authorisation holders must declare the quantities
before 31 January each year) and ii) the score assigned to the product. This
score varies in accordance with the hazard categories assigned to the product
and is given at the stage of product authorisation. In doing so a clear
financial incentive is given to those companies wishing to place on the
market a biocidal product that bears lower risk properties.
Also in Austria, France, Germany, Luxemburg and Sweden fee-based
approaches are applied or are being developed. An example is the reduced
fee under the simplified authorisation procedure.
2.2.
Effective approaches of monitoring the use – Article 18 (b)
2.2.1. Analysis
The survey revealed that in order to have a better overview regarding the
placing on the market and the use of biocidal products in the EU, the
monitoring of the use of biocidal products should be performed in a
9
European Commission, ‘Guidance concerning a Harmonised Structure of Fees’, CA-Dec12-Doc.5.1.bFinal
8
harmonised way. Monitoring of the use of biocidal products requires
however data collection. To date very little information is collected by the
Member States on the use of biocidal products. It appears that of those that
do, the data collected is mainly limited to sales data, rather than data on
actual use. Only four Member States are collecting data on the use of
biocidal products or will do so in the future, and in two of these Member
States this requirement only covers biocidal products for professional users.
A possible way to respond to this need has been anticipated by Regulation
(EC) No 1185/2009 concerning statistics on pesticides10 (hereafter the
Statistics Regulation). This Regulation stipulates that its scope can be
extended in order to cover biocidal products too. Article 3 of the Statistics
Regulation sets out that Member States are obliged to collect the data
necessary for the specification of the characteristics listed in Annex I
(statistics on the placing on the market of pesticides) on an annual basis and
for the specification of the characteristics listed in Annex II (statistics on
agricultural use of pesticides) in five-year periods.
However, when it comes to the practical implementation of monitoring use
of biocidal products, the Register for Biocidal Products (commonly known
as the "R4BP") might be a more appropriate tool to collect data and support
a harmonised approach. The R4BP is hosted and administered by the
European Chemicals Agency (ECHA) and is used for the exchange of
information between applicants, Competent Authorities, the Agency and the
Commission. In addition, it has to be used by applicants to submit
applications and data for all procedures covered by the BPR.
2.2.2. Conclusion
In 2008, at the time of negotiating and publishing the Statistics Regulation,
neither the Commission nor most Member States had sufficient knowledge
or experience to propose to include measures regarding biocidal products. It
was also clear that the effects of Directive 98/8/EC would not become
apparent until the review programme of existing active substances would
have made substantial progress.
Furthermore, the Commission is not due to report on the implementation of
the Statistics Regulation until the end of 2016. So therefore it is unlikely that
steps will be taken shortly to amend the Statistics Regulation, in particular to
extend its scope to the use of biocidal products.
In the intervening period the BPR was introduced, which required the
Commission to consider the most effective approaches for monitoring the
use of biocidal products. Therefore, if an appropriate approach relying on the
R4BP is found, no amendment of the Statistics Regulation might be
required.
Regarding the approach to be followed, as stated above, the R4BP would
seem to be the most appropriate solution, as it will eventually provide a
10
Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009
concerning statistics on pesticides, OJ L 324/1, 10.12.2009.
9
mean of communication with every authorisation holder, making it thus
more easy to implement a reporting scheme.
To that effect, Article 68(2) of the BPR on record-keeping and reporting
empowers the Commission to adopt implementing measures to specify the
form and content of the information in the records to be kept by
authorisation holders.
However, more important than the form and the content of the information
to be kept, it remains to be clarified what would be the purposes of
collecting this information and how it could support the objectives of the
BPR.
A balance should also be sought between information which can be easily
collected and reported and more detailed information which would require
more resource for both collection and analysis. But again, the purpose of the
collection should be defined first.
2.3.
Applicability of IPM – Article 18 (c)
2.3.1. Analysis
The Sustainable Use Directive11 establishes a framework for Community
action to achieve the sustainable use of pesticides. Article 14 and Annex III
of that Directive sets out the general principles for integrated pest
management (IPM), which can be of relevance to biocidal products. These
principles touch upon the requirement of monitoring of harmful organisms,
the consideration of the use of alternative and non-chemical methods.
Further they consider the decision as to whether and when to apply plant
protection products, the choice of the right plant protection product and the
use of the appropriate amount of product necessary. In addition it requires
the application of available anti-resistance strategies and to check the
success of the product applied.
It is however important to note that in the case of plant protection products,
compliance with IPM principles is linked to the payment of agricultural
subsidies. It is therefore a very strong incentive, which has no equivalent
within the field of biocidal products.
Aside from the IPM principles set out in Article 14 and Annex III, there are
other provisions of the Sustainable Use Directive that can be relevant to
biocidal products. These include Article 4 on national action plans, Article 5
on training, Article 6 on requirement for sales, Article 7 on information and
awareness-raising, and Articles 8 and 9 on equipment and methods of
application.
11
Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a
framework for Community action to achieve the sustainable use of pesticides, OJ L 309, 24.11.2009
10
2.3.2. Conclusion
Due to the number and diverse nature of biocidal products, it is not
appropriate to look simply at extending the scope of the Sustainable Use
Directive to biocidal products. It would be more appropriate to adapt the
principles of IPM to specific biocidal product-types, as part of the
development of best practices for each product-type. IPM principles are
most suited to be adapted to product-types 14 (rodenticides) and 18
(insecticides). It should be noted that principles of IPM are already
integrated in the 'Guideline on Best Practice in the Use of Rodenticide Baits
as Biocides in the European Union'12. In that guidance, IPM principles are in
particular applied to the outdoor use of second generation anticoagulant
rodenticides. This guideline provides advice on how to monitor for the
presence of rodent infestations without the permanent application of
rodenticide baits. It discusses alternatives to rodenticides, provides practical
guidance to be followed in different circumstances of rodenticide use, and
describes what to do before, during and after rodenticide application. The
guidance document also refers to sources of information on anticoagulant
resistance and how to manage it. Likewise it provides links to further
information on rodent control that is available from other organisations and
authorities.
When the IPM principles are considered as suitable for biocidal products,
similar approaches have been developed, which integrate preventive
measures, monitoring and a reasonable use of biocides. The concept of
Hazard Analysis and Critical Control Points (HACCP), which is applied in
the food industry, the health care sector, in swimming pools or in the
drinking water industry is an illustration of how the IPM approach can be
transposed to the many sectors where biocidal products are used.
Also, some of the best practices guides developed in other sectors also
integrated the principles of IPM regarding the use of biocidal products in
these sectors.
Regarding national action plans, it should be noted that one Member State
(Belgium) has developed a Programme for the Reduction of Pesticides and
Biocides, and thus included biocides within its action plan for pesticides.
Furthermore, a number of Member States are also in the process of
developing their own strategies for the sustainable use of biocidal products.
These developments at the national level serve as useful examples to other
national authorities that may be encouraged to take a pro-active role in the
sustainable use of biocides. These initiatives at Member State level are
welcomed.
Article 5 of the Sustainable Use Directive requires Member States to ensure
that all professional users, distributors and advisors have access to
appropriate training by designated bodies and have established certification
systems. According to the information collected, public systems of certified
12
http://www.rrac.info/content/uploads/CEFIC-EBPF-RWG-Guideline-Best-Practice-for-Rodenticide-UseFINAL-S-.pdf
11
training are in place in approximately half of the Member States13, in
addition to training operated internally by companies.
From a review of the systems of certification in operation in the Member
States, development of certification is already well advanced in most
Member States in the field of disinfection and pest control, and will be aided
by the development of the CEN 16636 standard for pest management
services. A certification scheme could also be considered for PT 8 on wood
preservation and PT 21 on antifouling products. Involvement of stakeholders
in this mainly industry-driven process is highly desirable.
With regard to information and awareness-raising as referred to in Article 7
of the Sustainable Use Directive, Member States are already required to
provide the public with appropriate information about the benefits and risks
associated with biocidal products and ways of minimising their use under
Article 17(5) BPR. Well-planned monitoring can help to target information
campaigns as much as possible.
2.4.
The need for additional measures to reduce risks in specific areas such
as schools, workplaces, kindergartens etc. – Article 18 (d)
2.4.1. Analysis
Product types 8 (wood preservatives) and 18 (insecticides) contain the
majority of active substances approved to date in accordance with the BPR.
Also a number of active substances for product types 19 (repellents and
attractants) and 21 (antifouling products) have been approved.
The analysis of these four product types showed that any risks to specific
areas are already addressed through use restrictions set in the conditions of
approval of the active substance or in those of the authorisation of the
biocidal products. Should further measures be required to ensure the proper
application of risk mitigation measures (RMM), these can largely been
pinned down to measures to increase the dissemination of information to the
end-user and to strengthen education and training.
2.4.2. Conclusion
In conclusion and looking at the majority views of respondents to the survey,
no specific measures, other than those taken during the authorisation stage,
seem to be necessary.
If after all a risk materialises, this is mainly as a result of poor observance of
the conditions of use of the product rather than there being a gap in the
protection in specific areas. As stated above, training and sharing of
13
A general certification scheme for professional users of biocidal products or training requirements and/or
certification for specific products, primarily in the area of pest control, are in place in: Austria,
Bulgaria, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Latvia, Malta, the
Netherlands, Spain and Sweden.
12
information is fundamental to ensure that RMM are appropriately applied in
order to protect specific areas.
Further legislative measures setting out an EU-wide restriction on the use of
biocidal products in specific areas are not recommended. After all, it remains
open to Member States to impose such restrictions as a condition of the
product authorisation on a case-by-case basis or through legislative measures
at the national level.
2.5.
The role of improved performance of equipment - Article 18 (e)
2.5.1. Analysis
Article 8 of the Sustainable Use Directive requires Member States to ensure
that pesticide application equipment in professional use is subject to
inspections at regular intervals.
In the biocides area, automated systems, ready-to-use products, calibrated
dosing and control systems, etc. are used.
Given the huge diversity in nature and application compared to plant
protection products, it should be noted that setting requirements relating to
equipment for application of biocidal products would require very
substantial work for an uncertain benefit. Furthermore, should specific
restrictions be desired, this could be done, on a case-by-case basis, by means
of specific conditions included in the substance approval or product
authorisation rather than imposing particular requirements for machinery or
equipment.
2.5.1. Conclusion
Harmonised measures on the performance of equipment for the application
of biocidal products are not required. The equipment used depends on the
particular application and biocidal product used. It can be assumed that in
case of the application for example by brushing, standards for equipment are
even less relevant. Where the application of biocidal products is done using
closed systems, exposure is avoided and dosage can be easily controlled.
Nevertheless, in all cases, equipment must be appropriate and adequate for
the product and where relevant, must be developed and appropriately
maintained and calibrated according to the instructions. Furthermore, it
should be noted that industry has developed a number of ready to use
products, such as pre-packed bait boxes, to ensure that the correct quantities
are used and unnecessary exposure is avoided.
In cases where dosage is not correct or inconsistent with the label, this is
often a result of the poor appliance by the user rather than poor or failing
equipment. Further steps can be taken with regard to training therefore.
Lastly, besides considering the equipment at the time of application, other
factors are also important in order to minimise exposure, such as the
selection of the appropriate product, determination of weather conditions,
the level of infestation etc. This again demonstrates the relevance of suitable
best practice instructions adapted to each product-type being available to the
users.
13
Based on the current information and experiences, few added value is
expected by extending the Machinery Directive for pesticide application
(2006/42/EC) as suggested in the amending Directive 2009/127/EC14.
3.
TOOLS TO STIMULATE INNOVATION AND PROMOTE SUSTAINABLE USE
Going beyond the scope of the provisions of Article 18, a brief analysis has been
made of a few other tools or actions that could be used to stimulate innovation and
the development of new products to decrease the environmental and human health
impact of biocidal products.
3.1.
The use of an 'eco-label' or other possible schemes
3.1.1. Analysis
The Commission services considered the possibility to attribute an eco-label
to biocidal products that demonstrated to have a better health and
environmentally friendly profile. The idea was to stimulate and support
innovation and development of such products by the biocide industry.
Besides the EU Eco label, there exist a number of voluntary schemes across
developed by industry that highlights the advantageous environmental and
health profile of particular products.
3.1.2. Conclusion
The analysis of the criteria under Regulation (EC) No 66/2010 on the EU
Eco-label15 shows that biocidal products are not suitable for an EU Ecolabel. These criteria are adopted by the EU Eco-labelling Board (EUEB) in
order to decide whether or not to evaluate a product group for an EU Ecolabel. In accordance with the EUEB’s policy document, it is noted that “the
scheme must prioritise those product groups where the use of the EU Ecolabel could make a significant contribution to more sustainable production
and consumption".
The aim is to show a significantly better environmental performance. Due to
the inherent nature of biocidal products, the purpose of which is to provide
an effective means to kill or control harmful organisms, it is probably that
those products that have a significantly better environmental performance
are the non-chemical alternatives available to biocidal products.
Furthermore, given the market share of biocides which is rather small
compared to plant protection products or pharmaceuticals and considering
the multiple sectors and the wide variety of products within it, there seem to
be hardly any interest from companies to apply, use and maintain an Ecolabel licence.
14
Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending
Directive 2006/42/EC with regard to machinery for pesticide application, OJ L 310/29, 25.11.2009.
15
Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on
the EU Ecolabel, OJ L 27/1, 30.1.2010.
14
Voluntary schemes developed by industry are welcomed but are not
considered useful to be promoted for an EU wide approach.
It might be more meaningful to look at the labelling provisions. Whereas in
the next section (3.2) the amendment of the advertising and marketing
provisions is considered, one could reflect upon specific labelling at the time
of product authorisation. The question can be raised whether, under strict
conditions, the authorisation/label can show an agreed statement indicating
the health and environmentally friendly profile of the concerned product.
On the long term it might be suitable to expand the features of R4BP in view
of providing a tool for the overview and selection of biocidal products that
have a lower impact on the environment and human health16. The first step
would however be to define what data and selection criteria can be used for
this purpose.
3.2.
Possible amendment of advertising and marketing provisions – Art 72
3.2.1. Analysis
The provision on advertising and marketing as laid down in Article 72 of the
BPR, prevents companies from making claims that their products have a
better environmental and human health profile, even when this would be the
case and would be acknowledged by Competent Authorities.
According to the information available, the position of Member State
authorities and NGO’s is that the current advertising restrictions set out in
Article 72 BPR are not too strict and should remain unchanged, while
industry stakeholders raised concerns in particular with regard to the
restrictions on the use of the terms ‘low-risk biocidal product’ and ‘natural’
3.2.2. Conclusion
The possible incentive and benefit that less restrictive provisions regarding
advertisement and marketing could bring to companies placing biocidal
products with a better profile for the environment or public health on the
market are acknowledged. On the other hand, those provisions have been
included with the clear objective of preventing misleading information on
biocidal products, which could also lead to the misuse of biocidal products.
Notwithstanding this, under the current regime, the potential user has hardly
any means to be informed about the possibly more favourable properties of
the product, such as a product authorised under the simplified authorisation
procedure. Making the choice for a 'sustainable' biocide starts with receiving
accurate information.
The Commission would therefore encourage further discussions with
Member States, with a view to develop an approach, whereby the
Competent Authority themselves would authorise statements in the label
indicating the health and environmentally friendly profile of the concerned
16
This is similar to the WIDES database in Vienna (Austria) which is developed to help professional users
making a choice of the most suitable disinfection product based on different criteria.
15
product, the type of statements which could be made and the criteria to be
met for products to be eligible to such statements.
4.
FINAL CONCLUSIONS
As stated in the introduction, the BPR is fully operational since 1 September 2013.
This means that only little experience is gained to date with the current legislation.
While the BPR does not regulate the use phase in details, it does include provisions
addressing the use phase. Under Article 17(5) of the BPR, biocidal products are to
be used in compliance with both the terms and conditions of the authorisation and
the labelling and packaging requirements. Article 17(5) goes on to provide that
‘proper use’ is to “involve the rational application of a combination of physical,
biological, chemical or other measures as appropriate, whereby the use of biocidal
products is limited to the minimum necessary and appropriate precautionary steps
are taken”. In other words, this is to be understood that ‘sustainable use’ does not
necessarily mean reducing the use of biocidal products to a minimum in all cases,
but about using biocidal products when necessary and in the correct amounts,
including also the primary consideration of other non-chemical methods of control.
Furthermore, as also stated in the introduction, substance approval, product
authorisation, comparative assessment of biocidal products containing candidates
for substitution with the aim of phasing-out their use, are already first and important
contributions to the objective of sustainable use of biocidal products. However, the
slow pace of progress of the review programme of existing active substance is a
serious impediment to the achievement of this objective.
The completion of this review programme together with the authorisation of all the
existing biocidal products in accordance with the BPR, shall therefore be the first
and main priority with a view to promote the sustainable use of biocidal products.
The BPR processes require extensive and often challenging efforts and resources
from both industry and Member State Competent Authorities. In a quickly changing
market, companies are facing long procedures before a product authorisation may be
granted. Whereas the major part of the review programme is still to be performed,
CAs need time to streamline the assessments relating to specific product types or
product groups. Therefore it would be reasonable to call for regulatory stability at
this moment in time and not opt for a legislative amendment of the BPR. Moreover,
the conclusions out of the previous sections demonstrate this is not essential. And as
indicated, there is no immediate need to focus on amendments of the Statistics
Regulation, the Sustainable Use Directive or the Machinery Directive in order to
include biocidal products in their scope.
So, taking into account this situation and recognising the relevant provisions of the
afore-mentioned legislations and practices it would make sense to focus on the
current implementation of the BPR.
Furthermore, the correct and safe use of biocidal products starts with having
appropriate guidance or directions for use. Whether this is for professional use or
not, there are a number of possibilities to explore. This involves not only the
development of guidance, but also the effective dissemination of it.
16
In case of industrial applications, when BREFs (Best available Techniques
Reference Documents) are developed, where relevant, best practice guidelines on
the use of biocidal products should be incorporated. The coordination is done by the
European IPPC Bureau (European Commission Joint Research Centre) and carried
out by technical working groups with experts from Member States, industry and
NGOs. Currently the application of wood preservation with chemicals is being
discussed to be included as a chapter in the BREF on Surface Treatment with
Solvents (STS). As explained in section 2.1.2 there is a clear benefit in
incorporating sustainable use guidelines in the BREFs. Where BREFs for sectors
using biocidal products are to be developed or revised, the necessity to include best
practice guidelines for biocides needs to be flagged already at the start of the
process.
Where it comes to non-professional use, emphasis should be put on the provisions in
the authorisation and the labelling of the product. Technical solutions like smart tags
or quick response codes (QR) providing a link to the manufacturers' website can be
helpful to consult about specific product properties and use instructions. In the
context of the study on Risk Mitigation Measures for anticoagulant rodenticides17,
some suggestions such as supplying additional information at the point of sale and
having trained people at these points of sale have been made.
Developing guidance documents and providing training and certification of the
users on application of best practices goes hand in hand. Especially for professional
users, EU harmonisation in terms of training and certification is elementary when
applying integrated pest management principles to the use of biocidal products
A good example has recently been developed in the area of pest management. In
recognition of this need to develop a common standard throughout Europe, prEN
16636:2013 was prepared by Technical Committee CEN/TC 404 “Project
Committee – Services of pest management companies”18. Following peer review by
17 European Standard Institutes, the draft standard received approval at the end of
2014 and was officially presented in March 2015. The standard will be published by
the end of September 2015 by CEN Members in 33 European countries.
EN 16636 specifies the requirements and competences to be met by professional
providers of pest management services in order to protect public health, assets and
the environment. It applies to those responsible for delivering pest management
services, including in the assessment, prevention, consultancy and execution of the
relevant control procedures. EN 16636 does not apply to field crop protection or
routine cleaning and disinfection associated with regular contract cleaning services.
Compliance with EN 16636 will enable pest management providers to demonstrate
that they have the necessary competence and know-how to deliver pest management
services. They have a management system to ensure a consistent level of quality,
they systematically minimise risks for clients and the public as well as for potential
negative impacts on the environment and animal welfare.
17
Commission study Risk Mitigation Measures for anticoagulant rodenticides as biocidal products, final
report – October 2014
18
CEN, European Committee for Standardisation
17
Such type of initiatives is to be welcomed as they directly contribute to the
sustainable use of biocidal products.
As pointed out earlier, the experience with the BPR is rather limited to reach a
definitive conclusion regarding the impact of the BPR on sustainable use. The
Commission will however keep the matter under scrutiny and will re-address it in its
report on the implementation of the BPR due by July 2021.
A possible roadmap with actions for the next years is outlined below:
•
•
•
•
•
•
•
Focus and strengthen efforts on the review programme of existing active
substance to ensure it is completed by end 2024.
Ensure that once active substances are approved, product authorisations are
granted, amended or cancelled within 3 years.
Benefit from the legislative tools available, in particular by closely following
the developments of BREFs that can be relevant for biocidal products.
Define what would be the objectives of monitoring the use of biocidal
products, what would need to be collected and how (examining what
solutions the R4BP could offer).
Discuss labelling requirements to allow specific statements for biocidal
products with a better profile for the environment or public health.
Encourage the use of smart tags or quick response codes (QR) on biocidal
products labels to provide further information on the product properties, its
instructions for use and elements to consider before using it.
In the context of CEN, support the development of standards that could
contribute to the sustainable use of biocidal products.
18