What will the European Commission's new
regulations on genetically modified (GM) food and feed and
traceability and labelling mean for enforcers? Nick Warburton
reports
The daunting task of developing a legal framework for GM foods
in the European Community has not been easy. GM remains a highly
emotive issue for consumers, many of whom are concerned about the
potential risks to human health and the environment (EHJ, November
2001, page 356). While the European Commission has sought to placate
consumers, it also recognises that GM products cannot be kept out
of the market indefinitely. Consequently, the new regulations have
been designed to enable the public to make an informed choice about
what they are consuming.
When the EC's regulation on GM food and feed comes into force in
April, all ingredients that contain or consist of genetically modified
organisms (GMOs), or contain ingredients produced from GMOs will
need to be labelled as such before reaching the final consumer or
mass caterers.1 This marks an expansion in the labelling requirements
to include not just the presence of GM material but also products
produced or derived from GMOs regardless of the presence of GM material
(see this month's EU news, page 379).
There are however, some cases where labelling will not apply, for
instance, where the adventitious presence of approved GM material
is below a 0.9 per cent threshold. Additionally, the EC has set
a 0.5 per cent threshold for allowing the presence of non-approved
GM material as long as it passes a safety assessment from scientific
committees at the European Food Safety Authority (EFSA). This threshold
will only apply for a three-year period. The new regulation also
will not apply to food that has been produced with GM processing
aids, for example, some cheeses, or products from animals that have
been fed GM animal feed.1
In the second, related regulation on traceability and labelling,
food operators will be required to put into place systems and procedures
to account for and identify GM products throughout the supply chain,
with the objective of facilitating accurate labelling. The EC's
intention is to provide a harmonised EU system on the documentation
that is needed to trace GM products from farm to table.
For products that consist of or contain GMOs, written documentation
must be transmitted throughout all stages of the supply chain. This
documentation must state that the product contains or consists of
GMOs, and provide the unique identifiers for the GMOs. Operators
will have to retain this documentation for five years. An alternative
traceablility procedure can be used for products that consist of
or contain mixtures of GMOs, which are to be used only directly
for food, feed or processing. This will entail a declaration of
use by the operator and a list of the unique identifiers "for
all those GMOs that have been used to constitute the mixture."2
In the case of food and feed that has been produced from GMOs,
written documentation must be transmitted to the operator receiving
the product for each transaction. The documentation must provide
an indication of each of the food ingredients, feed materials, or
feed additives, which is produced from GMOs. If no ingredients list
exists, an indication that the product is produced from GMOs must
be documented. As with the products consisting of or containing
GMOs, all operators must retain the documentation for a period of
five years.
There will be a requirement to carry out inspections and other
control measures once the regulations are introduced, including
sample checks and testing to ensure compliance. The EC is currently
consulting on the technical aspects of implementation, ie the unique
identifiers and the sampling and testing methods and this information
will be available in due course.
In the meantime, the Food Standards Agency and the Department for
the Environment, Food and Rural Affairs, which share responsibility
for the implementation of the new regulations into UK law, announced
plans in November to issue a joint consultation on the draft domestic
legislation. The FSA and Defra have also said that they will produce
draft guidance to accompany the regulations and a draft regulatory
impact assessment by the end of the year.1
But in what ways will the new regulations affect local authority
enforcement? According to Jenny Morris, CIEH policy officer, this
will depend on the regulatory set up, but in principle, environmental
health officers should be able to enforce it anywhere that they
enforce labelling legislation. She believes that potentially, there
are huge enforcement issues, particularly with regard to traceability
and labelling in cash and carry outlets and catering establishments.
"As the traceability requirement is a 'one up and one down',
the implication for cash and carries, where products are not sold
to the final consumer, is that they will need to be able to identify
individual purchases of GM products and maintain the records for
five years. For caterers, it is not so straightforward and guidance
will be needed, 'may contain' labelling will not apparently be appropriate."
A month prior to the regulations being announced, the CIEH issued
a professional practice note for EHPs, which focused on enforcement
in the catering and retail environments where, at present, there
is little professional guidance.3
The historical division of enforcement responsibility in parts
of the UK has meant that food law has often been referred to as
either food hygiene law or food standards law. Environmental health
departments are responsible for enforcing food standards law (the
labelling, description, composition and ingredients of food) in
Northern Ireland, Scotland, London, and in some English metropolitan
districts and unitary authorities in England and Wales.
In legal terms, food enforcement bodies must uphold five essential
objectives in food standards law, including providing consumers
with information, facilitating product traceability and protecting
public health. While GM is not defined as a food safety issue in
food law, the results of the first nationwide public debate on GM
and GM crops, published in the report GM nation? reveals that the
UK public generally remains uncertain and cautious towards GM.4,
5
The public debate, which was jointly funded by Defra, the Department
for Trade and Industry and the devolved administrations in Scotland,
Wales and Northern Ireland examined a diverse range of issues, one
of which discussed the regulatory process and its impact on GM food
safety. Not surprisingly, considering the emotive nature of the
subject matter, opinions were divided.6
On the one hand, advocates of GM claimed that a "rigorous
and extensive testing regime" exists to protect the consumer.
Independent scientists and regulators in the UK, EU and worldwide
will ensure that claims made about safety in relation to human health
and the environment are substantiated, and until these regulatory
bodies are satisfied that GM food is as safe as non-GM, GM cannot
be sold to consumers. The main stumbling block in this argument
for opponents is that GM is still a new process and as a result,
it cannot be claimed with any certainty that it will be safe in
the long term.
Whatever happens, when the domestic legislation comes into force
next April, the public will expect it to be rigorously enforced.
According to the CIEH's practice note, surveys have shown how importantly
consumers view the effective enforcement of food standards law.
Many consumers take an active interest in the ingredients or nutritional
value of food for a wide range of reasons. Purchasing decisions
can be influenced by cultural, ethical or moral beliefs and an increasing
number of consumers regulate their diet for health reasons.
By law, consumers have to be given certain key information about
food that is being sold. But this can vary, for example on whether
the food is being sold in retailers or catering establishments.
Food sold in catering establishments, such as restaurants, pubs,
clubs and canteens, has not up to now required much description
or labelling by law, although when information is provided, it must
be accurate and not mislead consumers. As a result, it is one of
the more difficult situations in which to enforce food standards
law.
Part of the problem lies in the fact that some of the information
which needs to be provided when food is supplied to catering establishments
will be found in commercial documents that accompany the food rather
than on the label. In fact, only the legal name, best before/use
by date, and name and address must be labelled on the food itself,
and this information is usually found on the outermost packaging.
This means that enforcement officers may need to examine invoices,
product specifications, data sheets, or any other paperwork that
arrived with the food to find the information that is needed to
verify compliance. However, many enforcement officers will be familiar
with situations in which the accompanying documentation is only
partially provided or has been separated from the materials. When
this happens, officers may have to go to great lengths to track
down the missing paperwork, which can be resource intensive. If
documentation is missing or incomplete, it also poses a challenge
for enforcement officers in tracing materials back in the supply
chain.
At this early stage, it is difficult to say whether enforcement
officers will see this as a priority area, particularly when GM
is not deemed a food safety issue. Nevertheless, being the emotive
subject that it is, there may well be public pressure for traceability
to be rigorously enforced.
As practitioners know only too well, the enforcement of food standards
law often relies on verifying that the food in question, and in
particular the ingredients and other constituents of the food, meets
certain criteria, for example, any legal compositional standards
that apply to the food. For this reason, taking samples of food
for analysis by the public analyst is one of the best means of enforcing
food standards law.
However, as Michael Reilly, lead food standards officer at the
Royal Borough of Kingston Upon Thames explains, sampling for GM
is an expensive, resource intensive and time-consuming process.
He agrees with the legislation in principle but is sceptical that
local authorities will see it as a priority and suspects that it
will be very difficult to enforce in practice unless performance
targets are imposed. If the legislation is to be effective, he argues,
there will be resource issues to consider.
Les Bailey, policy officer for food standards at the Local Authority
Co-ordinators of Regulatory Services (Lacors) disagrees in terms
of enforcement activity. He believes that local authorities will
see enforcement of the new legislation as a priority, partly because
of the emotive nature of the subject matter. Public interest in
GM may, he argues, even influence how local authorities allocate
their resources. He does however, acknowledge that the time consuming
nature and expense of sampling, which on average ranges from £600-£1,000
per sample, may act as a deterrent for local authorities to carry
out much work.
There is another sampling issue that needs to be considered, relating
to the 0.9 per cent threshold for the adventitious presence of approved
GM material. Although it is possible for public analysts to identify
GM at a very low level, once the material becomes a compound product
or complex mixture, there is a problem with quantification.
"Unless you are able to test the raw materials, it is very
difficult," says Carol Stevens, public analyst for Worcestershire
County Council. "Once GM has been incorporated into composite
food, testing becomes an arm's length process. The only way back
to the source is through audit trails and documentation". While
Ms Stevens agrees that getting hold of the exact standard is problematic,
she says that the same difficulties apply to organic materials.
She also stresses that she has not seen much evidence of the deliberate
incorporation of GM at low levels. Under the new rules, she concludes
that it will be impossible to test for GM and that verification
will completely rely on audit trails and documentation.
Last year, the first GM-labelling prosecution in the UK was brought
following a visit to a supermarket in Leamington Spa by trading
standards officers at Warwickshire County Council in February 2001
(EHN, March 22, 2002, page 4).
A DNA test carried out on a sample of soya mince taken from an
unlabelled packet showed that the product contained more than 50
per cent GMOs. When the shop was able to show that it had taken
due care, liability passed to the food packer, who had been buying
in bulk soya chunks and repackaging them to sell nationally and
internationally. In this case, the packer had failed to pass on
information from the supplier about the presence of GM material
in the product.
Commenting on the case, Richard Brook, divisional trading standards
officer at the council, says, "One of the clear lessons from
the prosecution is that effective enforcement is down to a combined
approach between the public analyst and enforcement bodies. There
needs to be very close joint working for the regulations to be effectively
enforced."
He says that local authorities would benefit from sharing information
about samples, as this would reduce costs, avoid duplication and
identify gaps in the system. Mr Brook is currently working on a
combined national enforcement database that is being funded by the
Office of the Deputy Prime Minister as part of the e-government
agenda. Part of the project's aim is to make sampling data available
to all local authorities to assist them in their enforcement duties.
While GM is not deemed a food safety issue, public concern on this
issue remains high. Consumers need protecting and enforcement of
the regulations is essential if the public is to make an informed
choice about what they are buying. Whether other enforcement bodies
will follow Warwickshire CC's lead and take a proactive stance on
GMOs has yet to be seen. What is clear is that enforcement can only
be effective if enforcement bodies and public analysts work closely
to ensure consumers are given the choices they demand.
References
Food Standards Agency press release, Date set for new GM food
regulation,
6 November 2003.
Joint Food Standards Agency and Department for the Environment,
Food and Rural Affairs summary of the key components of the new
regulations on GM food and feed and traceability and labelling,
14 October 2003.