Hazard vs Risk R I SK
HAZARD
The Importance of Dosage REMEMBER
E X P OSUR E
It’s the dose that makes the poison
Animal Testing
Pesticides:
Animal testing
A guide to the stringent
is required under
scientific testing required
EU law to ensure
by EU Regulation
Hazard is not the same as risk.
Many substances that are vital in small amounts
that pesticides,
There is often confusion between the terms
can be lethal in large doses.
and other chemicals,
hazard & 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
HERE’S AN EX AMPLE OF HAZARD VS RISK
Research
The body needs
BUT
salt HAZARD
Approval
pears
The likelihood
naturally
of harm being
contain
done and
formaldehyde (0.0001g/kg)
Pesticides are some of the most rigorously tested chemical products in the world.
by applying
Many fruits
R ISK
that harm
TO
animal testing
a child.
BUT
Formaldehyde
including
HIGH RISK
hard to minimise
a fatal dose for
cause harm
the extent of
industry works
57g of salt is considered
Anything that can
LOW R I S K
The pesticides
can be deadly if consumed at high concentrations.
intelligent testing strategies, in line with ECPA's commitment to the “3 R's Principle”:
Ingestion of as little as 30ml of a solution containing 37% formaldehyde has been reported to cause death in adults.
1
2
3
REFINE
REDUCE
REPL ACE
1
1
Medical Management Guidelines for Formaldehyde
ecpa.eu @cropprotection
PHASE 2
PHASE 3
Research
Development
Each pesticide manufacturer has its own
Much of the testing in this phase will
Approval and Registration
Reviews and Controls
unique 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 chemicals.
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.
P O T E N T I A L LY M A R K E TA B L E CHEMICAL
Laboratory Practice.
A company submits test & study results to a designated national authority for approval
an agrochemical company screens H U N D R E D S O F T H O USA N D S O F SU B S TA N C E S
...TESTING SCALES UP SIGNIFICANTLY
The evaluation is carried out by one Member State
IN THE
TE S T S
DEVELOPMENT PHASE
cover chemistry, biology, toxicology and environmental chemistry.
the manufacturer and the authorities to ensure that they meet the most up to date safety standards.
Member States
THAT THIS SUBSTANCE WILL BE BROUGHT TO THE MARKET
And is approved by the European Commission
Member States authorise & register products containing the substance for use on the national market
and reproducability of chemical testing.
F R O M R E S E A R C H TO A P P R OVA L
11
BET WEEN
2005 - 2008
2010 - 2014
the cost of
this cost
discovery and
increased to
development of
€215 million
a pesticide was
refers to a high quality system for research laboratories and organisations to ensure the quality, reliability, integrity
PE S T I CI D E:
BET WEEN
YEARS
€189 million
AN
11.7%
INCRE A SE
Source: The Core of New Agrochemical Product Discovery,Development and Registration in 1995, 2005-8 and 2010 to 2014. Phillips McDougall. March 2016.
2017 - ecpa.eu
CHANCE
routinely reviewed by both
and all the other
GO OD L AB OR ATORY PR AC TICE
60%
Older products must be
Reviewed by EFSA
TESTING STARTS SMALL…
BY THE END OF THE RESE ARCH PHA SE, THERE IS A
A PERPETUAL REVIEW
as laid out by the OECD principles of Good
To identify
ONE
ONGOING
PHASE 1