Borderline between plant protection products
and biocides with regard to registration and
use
SUI Conference 2013, 11th-12th Bratislava
Laurent Oger
Laurent.oger@ecpa.eu
Overview
Scope
Legislative evolutions
Common elements of both legislations
Qualification criteria
Examples of borderline biocide cases
Examples of borderline PPP cases
The example of rodenticides
Situations of dual authorisations
Scope
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Food and feed area
Veterinary hygiene
Drinking water
Disinfectants and
algeacides
Human hygiene
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For wood
For liquid-cooling and processing
systems
For products during storage
For film
For construction materials
Slimicides
For fibre, leather, ribber and
polymerised materials
Amenity
Disinfectants
(PT 1-5)
Agriculture
Plant
Protection
Products
Preservatives
(PT 6-13)
Biocidal
products
Forestry
Others
products
(PT 21-22)
Pest control
(PT 14-20)
Horticulture
Home & Garden
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Rodenticides
Avicides
Molluscicides, vermicides…
Piscicides
Insecticides, acaricides…
Repellents and attractants
Control of other vertebrates
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Antifouling products
Embalming and
taxidermist fluids
Legislative evolution
Directive 91/414/EEC
concerning the placing of
plant protection products
on the market
Directive 98/8/EC
on the placing on the
market of biocidal
products
Regulation 528/2012
concerning the
placing on the
market and use of
biocidal products
?
Directive 128/2009
on the sustainable use of
pesticides
Regulation 1107/2009
concerning the placing
of plant protection
products on the market
?
Common elements
Active Substance approval at EU level
Product authorisation at Member State level
 Exclusion criteria and derogations
 Candidates for substitution and comparative assessment
 Sustainable Use of products
 Harmonization and simplifications procedures
Qualification criteria
Identification of the relevant legislation – some definitions
‘biocidal product’ means
any substance or mixture, 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
‘harmful organism’ means an organism, including
pathogenic agents, which has an unwanted presence or a
detrimental effect on humans, their activities or the products
they use or produce, on animals or the environment;
‘plants’ means live plants and live parts of plants,
including fresh fruit, vegetables and seeds;
‘plant products’ means products of plant origin in an
unprocessed state or having undergone only simple
preparation, such as milling, drying or pressing, but
excluding plants;
PPPs: products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or
synergists, and intended for one of the following uses:
(a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless
the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or
plant products;
(b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;
(c) preserving plant products, in so far as such substances or products are not subject to special Community provisions on
preservatives;
(d) destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect
plants;
(e) checking or preventing undesired growth of plants, except algae unless the products are applied on soil or water to protect
plants.
Criteria for borderline cases

Consideration of the written exclusions within the
scope of each legislations (articles 2 and 3 of
1107/2009 and 528/2012)
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In case of unclear or borderline situations for a
product the European Commission developed
specific guidance document on borderline cases:
•
Available at :
http://ec.europa.eu/food/plant/protection/evaluation/bo
rderline_en.htm
•
Manual of Decision available (regularly updated)
Step 1: Define the intended purpose of the product
Criteria of the target organism.
• If detrimental to plant or plant products then
it is a PPP
• If it is detrimental to other areas it is
considered as a Biocide
Criteria for borderline cases
Prevent introduction
of foreign
species/pathogens
 Protection against harmful organisms to plants and plant
Protection of the
wood
products: PPP
: where the products are used, even inside
• Directly
or outside
• Indirectly: PPPs in condition that the purpose is to
destroy exclusively and specifically organisms
harmful to plants or plant products (e.g storage
area)
 Products used for a general hygiene purpose: biocide
Step 2: The place where the product is applied to
achieve the principal intended action.
Examples of PPPs
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Space disinfectants in growing houses or greenhouses.
Products to control growth or penetration of plant roots and sprouts.
Products for use against garden snails
Products for the disinfection or the disinfestation of empty store
rooms or other structures if after the treatment only plants or plant
products will be grown or stored there.
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Products for post-harvest treatment of fruits and vegetables against
plant diseases
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Repellents used to treat seed, fruit trees or forestry against birds
Products to protect trees or other plants from damage by squirrels or
wildlife
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All herbicides regardless of whether they are applied to soil, water or
other surfaces
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Algaecides applied on soil or water to protect plants
Arthropod growth regulators and other pheromones used to control
organisms harmful to plants or plant products.
Examples of biocides
It should include products used for there
general hygiene function. Disinfectants in empty
structures when it is not clear which kind of
products will be stored after the treatment.
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Products for hygiene purposes to be used in greenhouses not intended for direct application to
plants.
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Products used on a hydroponic systems to control harmful organisms.
Products intended for the control of harmful organisms (other than plants), on surfaces like tennis
courts, car parks and tombstones, concrete, pavements and walls.
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Products used against snails to prevent humans and animals disease transmission.
Products used against snails that clog water pipes.
Products to destroy dust mites from textiles.
Fumigants used in storage rooms for food
Repellents against cats, dogs and snakes
Products added to water to wash fruits for public hygiene
Products for the control of termites when used as a bait or as a soil-drench treatment
Products for the control of birds for hygiene purposes
The example of rodenticides
There main purpose is considered to be for human hygiene
 All rodenticides are considered as Biocidal Products:
• Exclusion of products used in plant growing areas to protect plants,
or to protect plant products temporarily stored in the plant growing
areas.
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Products used outside the plant growing areas: in farms, cities, industrial
premises are biocidal products.
Products used inside the plant growing areas not to protect plant or plant
products (agricultural field, greenhouse, forest) are biocidal products.
Products used inside the plant growing areas to protect plants or plant
products temporarily stored here are PPPs.
Situations of dual authorisations
A same product can be used in several situations and fall under both
legislations.
Dual authorisation:
 x2 dossiers
 x2 contacts with different rapporteur Member states
 x2 fees
• In case of similar conditions of use authorities should coordinate
(even internally) and give a clear answer under which legislation
to be regulated.
E.g indoor products
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Coordination at EU level and experience sharing between
Member States should allow pragmatic solutions and the
limitation of borderline cases.
Thank you for your attention