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Hazard vs Risk The Importance of Dosage Animal Testing

Pesticides and
R I SK HAZARD E X P OSUR E
REMEMBER

It’s the dose that makes the poison


Animal testing biopesticides
is required under
A guide to the stringent
EU law to ensure
Hazard is not the same as risk. Many substances that are vital in small amounts that pesticides,
scientific testing required
There is often confusion between the terms can be lethal in large doses. and other chemicals, by EU Regulation
hazard and risk, causing them to be used are safe for humans
incorrectly. There is a fundamental difference HERE’S AN EX AMPLE and the environment.
between the two.

FROM
The body
HERE’S AN EX AMPLE
OF HAZARD VS RISK needs BUT
The pesticides Research
salt industry works
57g hard to minimise
HAZARD
of salt is considered animal testing
Anything that can
a fatal dose for TO
cause harm
a child.
Approval

LOW R I S K by applying
Many fruits BUT
intelligent testing
These substances are some
including Formaldehyde strategies, of the most rigorously tested
R ISK pears can be deadly in line with ECPA's products in the world.
The likelihood naturally commitment to the
if consumed at high
of harm being contain “3 R's Principle”:
concentrations.
done and formaldehyde
the extent of (100μg/kg) Ingestion of as little as
HIGH RISK 30ml of a solution containing
that harm
37% formaldehyde has been
reported to cause death 1 2 3
in adults. 1
REFINE REDUCE REPL ACE
ecpa.eu
1
Medical Management Guidelines for Formaldehyde @cropprotection
PHASE 1 PHASE 2 PHASE 3

Research Development Approval Reviews


and Registration and Controls

ONGOING
Each manufacturer has its own unique Much of the testing in this phase will
research strategy to find potentially consider the safety for humans, animals Before a substance is approved in the EU, A substance approval or product
suitable, safe substances. and the environment, it is often designed more than 100 specific tests are conducted registration may be reviewed
and conducted by independent bodies, to ensure its safety. by authorities at any time in light
adhering to international testing obligations of new scientific evidence.
To identify as laid out by the OECD principles of Good
P O T E N T I A L LY Laboratory Practice. A company submits test and
ONE

A PERPETUAL REVIEW
M A R K E TA B L E
study results to a designated Older products must be
PE S T I C I D E O R
B I O PE S T I C I D E national authority for approval routinely reviewed by both
an agrochemical company screens the manufacturer and the
H U N D R E D S O F T H O USA N D S authorities to ensure that
O F SU B S TA N C E S they meet the most
...TESTING The evaluation is carried out
SCALES UP up to date safety
by one Member State
SIGNIFICANTLY standards.

IN THE
TE S T S DEVELOPMENT
cover chemistry, biology, PHASE Reviewed by EFSA
efficacy, toxicology and all the other
and ecotoxicology Member States BET WEEN BET WEEN

TESTING 2005 - 2008 2010 - 2014


STARTS SMALL… European Commission the cost of this cost
GO OD submits a decision proposal discovery and increased to up to
L AB OR ATORY to a Member States’ development of
PR AC TICE Committee vote
a substance was €215 million
BY THE END THAT THIS refers to a high quality system up to AN
OF THE
RESE ARCH
PHA SE,
60%
CHANCE
SUBSTANCE
WILL BE
BROUGHT TO
for research laboratories and organisations which
allows regulatory authorities to independently
Member States
authorise and register products
€189 million 11.7% INCRE A SE

assess the quality, reliability, integrity


THERE IS A THE MARKET containing the substance for use
and reproducibility of testing.
on the national market Source:

2019 - ecpa.eu
UP TO

11
The Core of New Agrochemical Product Discovery,Development
PE S T I C I D E A N D B I O PE S T I C I D E : and Registration in 1995, 2005-8 and 2010 to 2014.
YEARS
F R O M R E S E A R C H TO A P P R OVA L Phillips McDougall. March 2016.

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