|
4.4
- REGULATORY ISSUES OF ENZYMES USED IN FOODS FROM THE PERSPECTIVE OF
THE EU MARKET.
Dr.
Danielle P. Praaning
DSM
Food Specialties, P.O. Box 1, 2600 MA Delft, The Netherlands
I.
INTRODUCTION
Enzymes
were already used for food production 2000 years before the birth of
Christ. Good examples are bread, cheese and beer production. Of
course, it was unknown at the time that it was the enzymes that were
doing the job. Nowadays, the production of food enzymes has become
industrialized. European enzyme manufacturers
are
market leaders and cater approximately 70% of the world's need for
food enzymes and this market is still increasing with an annual
growth of about 2%.
These
developments have triggered the creation of national laws and
regulations to ensure both the safety of the consumer and fair trade.
Although many laws in the European Union have been harmonized over
the last few decades, this has not (yet) happened in the case of enzymes.
The
European Association of Manufacturers of Fermentation Enzyme
Products (AMFEP), which was founded in 1977, has set as one of its
major aims the achieving of the widest possible harmonization of
regulatory requirements for enzymes in the EU. In order to achieve
this, AMFEP has initiated discussions with the European Commission,
National Authorities and the Food Industry.
This
Chapter presents an overview of the tangle of present regulations
that are applicable for enzymes when used in food.
II.
OVERVIEW OF APPLICABLE LAWS
In
the European Union, there are so-called "horizontal" and
"vertical" laws. Horizontal laws are those that cover all
foods. Examples are the laws regarding additives and those regarding
the labeling of foodstuffs.
Vertical
laws cover foods with a so-called standard of identify, also called
compositional regulations or "recipe laws." Examples of
products for which such standards exist are cheese and bread.
In
both cases, vertical as well as horizontal, there are laws that have
been harmonized throughout the EU and laws that are still subject to
national legislation. This situation will probably remain so,
especially in view of the fact that in the treaty which was signed in
Maastricht (The Netherlands) in Feburary 1992 (1), the European Union
officially laid down the principle of subsidiarity, which states that
the European Commission should not regulate what could be done just
as well or better at the national level.
For
products regulated solely at the national level, the principle of
mutual recognition applies. If a product is legally produced in one
country, it can also be sold in another EU country, unless this
country has well-founded arguments to reject the product on the
grounds of protection of consumer health, or one of the other reasons
listed in Article 30 of the Treaty establishing the European
Community (2). Other than in this situation, Member States are not
allowed to create unjustified trade barriers.
If
one wants to place a new enzyme on the market, any of the four cases
(horizontal versus vertical, harmonized versys national can be
applicable, meaning that all possibilities have to be assessed.
The
following factors are of importance when establishing how a specific
enzyme is regulated:
(i)
The purpose of its use. Is the enzyme used only during processing of
the food, or does it still have a specific function in the final food
that is sold to the consumer?
(ii).
The type of food in which the enzyme is to be used. Does the food in
question have a standard of identify?
(iii).
The country in which the enzyme is to be used in food. Applicable
non-harmonized regulations will differ country by country.
(iv).
The origin or source of the enzyme. Industrial enzymes can be
obtained from plant, animal or microbial sources. These may be
regulated differently. Moreover, some countries have special
requirements for those enzymes that are produced by genetically
modified organisms (gmos).
III.
EU HARMONIZED LAWS
A.
Horizontal Harmonized Laws
The
relevant harmonized EU Directive is the "Council Directive
89/107/EEC Concerning Food Additives Authorized for Use in Foodstuffs
Intended for Human Consumption" (3), also called the Additives
Framework Directive.
According
to this Directive, additives are everything added to food that is
not normally used as a characteristic ingredient (a characteristic
ingredient would, for instance, be milk in cheese or flour in bread).
In
the Directive, food additives are divided into those that have a
technological effect in the finished product and those that do not
have a technological effect in the finished product.
Additives
of the first category may only be used if they have been authorized
and included in a positive list together with their so-called
E-number and, if applicable, permitted applications. Moreover, their
presence in the final food has to be declared in the ingredient list
of the foodstuff.
Additives
of the second category are exempt from these obligations; thus they
do not have to be authorized, nor labeled on the final foodstuff. It
is rather confusing in practice that only products in the first
category are called additives, whereas products in the second
category are called processing aids.
The
precise definition of processing aid according to the Additives
Directive is:
"
'Processing aid' means any substance not consumed as a food
ingredient by itself, intentionally used in the processing of raw
materials, food or their ingredients, to fulfill a certain
technological purpose during treatment or processing and which may
result in the unintentional but technically unavoidable presence of
residues of the substance or its derivatives in the final product,
provided that these residues do not present any health risk and do
not have any technological effect on the finished product."
In
the case of enzymes, the distinction between the use as processing
aid or additive (or even ingredient) is not always easy. The existing
definitions in EU law are open to interpretation on a number of
points. This makes it difficult to decide in certain applications
whether an enzyme has the status of a processing aid or an additive.
The lack of consistence in the legislation has already led to
regulatory uncertainty and difficulties surrounding enzymes, which
until now had been regarded as processing aids, suddenly being
considered to be additives.
Recent
attempts to bring an increasing number of enzymes within the scope
of the definition of food additives have principally been based on
the argument that it is only possible to speak of a
"residue" when there has been a conscious effort made to
remove the enzyme.
However,
the interpretation of the food industry, and most authorities shared
this interpretation until now, has always been that if an enzyme does
not have a technological function anymore in the final food, it is a
processing aid, even if it remains in the final food in the small
quantity (ppm) in which it was added.
If
an enzyme does have a technological function in the final food,
however, it will fall under the Additives Directive. There are
presently only two enzymes falling under the Additives Directive.
(i).
Lysozyme, when used as preservative in ripened cheese.
(ii).
Invertase, when used for soft centered confectionery.
Confusingly,
these very same enzymes may also be used as processing aids for
other food applications!
Thus,
in the case of enzymes, one and the same enzyme can fall under both
categories, depending on its application. If the enzyme has a
technological function in the final food, it will fall under the
Additives Directive. If it does not have a function in the final
food, it is a processing aid and exempt from the Additives Directive.
Only
in case the use of an enzyme falls under the Additives Directive,
does specific approval by the European Commission need to be obtained
if a company wants to market a new enzyme. This means that the
functionality of the enzyme product has to be proved and its safety
has to be evaluated by a specific group of experts called the
Scientific Committee on Food (SCF).
In
1991 the SCF published guidelines for the presentation of data on
food enzymes (4). To obtain approval, toxicological data need to be
submitted. According to the guidelines, two mutagenicity studies and
a 90 days oral toxicity study in the rat are required as a general standard.
However,
safety data are not required for enzymes originating from edible
plants or animals. Presemably, the SCF did not think about enzymes
obtained from genetically modified plants at the time these
guidelines were made.
In
the case of microbial enzymes, no safety data are needed if the
micro-organism in question has a long history of safe use in food,
and belongs to a species for which documented evidence exists that no
toxins are produced, and the actual strain used is of well-documented
origin. To date, the only such microorganism accepted by the SCF is
Saccharomyces cerevisiae (bakers yeast).
B.
Verticle Harmonized Laws
There
are only two vertical harmonized Directives, those on fruit juices
and on wines, in which the use of certain enzymes is expressly
provided for.
The
Fruit Juice Directive (5) states that only pectolytic, proteolytic
and amylolytic enzymes may be used in fruit juices. The Wine
Regulation (6) permits the use of pectolytic enzymes and of
beta-glucanase from the microorganism Trichoderma harzianum only. No
other enzymes can be used, unless specific authorization, resulting
in an amendment of the law, is given.
IV.
NATIONAL LAWS
National
laws covering the use of enzymes are:
(i).
The general National Food Safety Laws. Even when an enzyme is not
regulated in a specific Member State, its use would be subjected to
the requirements of General Food Safety Legislation, which stipulates
that nothing must be added to food which renders it injurious to health.
(ii).
Horizontal enzyme regulations. There are three EU countries having
specific horizontal enzyme regulations; they are Denmark, France and
the UK (see below).
(iii).
Before Spain and Portugal had to implement the harmonized EU
Additives Directive, these countries regarded all enzymes, whether
used as additive or processing aid, as additives. As a consequence,
they were mentioned on the positive additive list and had t be
authorized as such. It may be confusing for these countries that only
very few enzymes are presently mentioned on the positive list of the
EU Additives Directive, while all other enzymes can still carry on
being used, albeit only as processing aids. These countries may see
this as a legal vacuum.
(iv).
In addition to the above mentioned regulations, most Member States
have vertical laws for cheese, flour, bread, etc. regulating the use
of enzymes. These vertical legislations differ from country to
country, which may not only create trade barriers, but also
contribute to a very complicated picture for enzyme producers and
users alike.
Unfortunately,
this is also an area where mutual recognition between Member States
does not function properly. If an enzyme is approved for a certain
use in one Member State, this does not automatically mean that it is
approved for the same use in another Member State.
A.
Horizontal Enzyme Regulations
In
the 1970's, the Joint Expert Committee on Food Additives (JECFA) of
the FAO/WHO developed toxicological requirements for enzyme products
(7) based on the following classification system:
(i).
Enzymes from edible tissues of animals
(ii).
Enzymes from edible parts of plants
(iii).
Enzymes from microbial origin:
a.
Microorganisms known to be present or used for food
b.
Microorganisms known to be harmless contaminants in food
c.
Microorganisms unknown in food
The
main conclusion from this classification was that no numerical
Acceptable Daily Intake, nor toxicity studies are necessary for
enzyme preparations derived from edible tissues of animals, from
edible portions of plants or from microorganisms that are
traditionally accepted as constituents of foods or are normally used
in the preparation of foods.
Moreover,
JECFA also established specifications to which enzyme products
should comply (8). These specifications cover limits for certain
heavy metals, microbial contamination, antibiotic activity and
mycotoxin content. In their guidelines, the SCF has largely followed
the JECFA safety classification and specifications.
Shortly
after JECFA development of specifications and toxicological
requirements, the UK, France and Denmark started developing
guidelines for food enzymes. These guidelines were all largely based
on the JECFA requirements and specifications. Only the French and
Danish guidelines have been turned into genuine enzyme legislation.
In the UK, it became a Code of Practice to ask for authorization for
a new enzyme preparation on the basis of the UK regulations.
In
principle, the French, Danish and UK enzyme regulations did not mean
to differentiate between the use of enzymes as additive or processing
aid. However, since the use of an enzyme as additive now falls under
the harmonized EU Additives Directive, these national laws now apply
to enzymes used as processing aids only.
In
all other EU Member States, there is no specific enzyme legislation.
As a result, enzymes when used as processing aids are merely
subjected to the general National Food Safety Laws if the country in
question has no horizontal law regulating enzymes and if the
application of the enzyme is not regulated in a vertical way. In such
cases, no authorization is needed if a company wants to put a new
enzyme on the market.
1.
National enzyme law in France
The
French enzyme Decree (9) permits the use of all enzymes mentioned in
an Annex to the Decree. This positive listing of enzymes is by
function, enzyme name, source, foods in which the enzymes are
permitted and special conditions for use. The list is being updated regularly.
The
French Decree also lays down specifications of purity, which are
very similar to the specifications laid down by JECFA. Furthermore,
permitted preservatives and diluents for enzyme preparations are listed.
To
obtain approval for a new enzyme, a dossier has to be filed with the
authorities. This dossier should contain proof of the functionality
of the enzyme ("case-of-need") and the results of safety
studies as described in the SCF guidelines. In case an already
approved enzyme is to be marketed for a new food application, only
the case-of-need is required.
2.
National enzyme law in Denmark
In
contrast to France, the Danish law (10) does not contain a positive
listing system. All enzyme products and their applications are simply
subjected to a notification procedure. Notification is valid only for
a specific brand or trade name.
The
user or importer of an enzyme preparation is responsible for such
notification. Recently, it has been decided that the information to
be contained in the notification should follow the guidelines laid
down by the SCF. Although the term "notification" is used,
there is in practice no real difference between this procedure and an
authorization. The authorities evaluate the dossier and the product
cannot be marketed until all questions about the dossier have been
satisfactorily answered.
3.
National enzyme regulation in the United Kingdom
In
the UK, the Ministry of Agriculture, Fisheries and Food published
the "Food Advisory Committee's (FAC) Report on the Review of
Enzyme Preparations" in 1982 (11). This document was meant to
form the basis for a national horizontal enzyme legislation.
The
FAC recommended that food enzymes should only be approved when a
technical case-of-need had been established and they were considered
safe for use in food. General specification requirements were also
outlined. Moreover, the FAC established a positive list based on
source and main enzyme activity. In this list, enzymes are divided
into two groups, A and B. Group A are enzymes of vegetable or animal
origin, for which no further specifications are necessary. Group B is
a selection of microbial enzymes, which are temporarily approved for
use in food. It was recommended that these enzymes be reviewed within
two years of the publication of the report.
As
a basis for such a review, the FAC recommended to develop a
non-specific screening test to prevent the marketing of microbial
enzyme preparations containing mycotoxins. However, the development
of the test turned out to be impossible for technical reasons.
As
an alternative, the UK Committee on Toxicity (COT) in 1993 published
"Guidelines for the Safety Assessment of Microbial Enzyme
Preparations" (12). These guidelines are comparable, although
somewhat more strict, to those of the SCF. No UK guidelines exist for
enzymes obtained from animals or plants.
Although
these COT guidelines have not been converted into a genuine law,
they have the same effect from a practical point of view.
Authorization on basis of the guidelines is required to achieve
marketing approval for a new enzyme preparation.
B.
Regulations for Enzymes Produced by Genetically Modified Organisms
(gmos)
The
SCF guidelines and the national regulations in the UK, Denmark and
France also cover specific provisions for enzymes made by gmos. In
simplified terms this means that the genetic modification will be
evaluated by the authorities before the enzyme can be approved and
that the enzyme preparation should be free of the gmo and recombinant DNA.
JECFA
has also written down general considerations and specifications for
enzymes from genetically modified microorganisms (13). This has not
been done for enzymes obtained from genetically modified plants or
animals. As has been the case for classical enzymes, these
considerations might be used for future EU regulations.
In
the Netherlands, a Novel Food law was passed in July 1993, covering,
among others, all additives and processing aids made by genetic
modification This law was issued because of the delays in the
adoption of the harmonized European Novel Food Regulation, but it has
now been replaced by the latter.
The
EU Novel Food Regulation was finally adopted in January 1997 and
entered into force in May of the same year (14). This Regulation
covers novel foods and food ingredients, but, in contrast to the
Dutch Novel Food law, additives (including processing aids) are
outside its scope.
During
the prolonged discussions on this Regulation, the European
Parliament obtained a commitment from the European Commission that an
investigation would be carried out as to the need to fill gaps in the
area regulating the protection of public health, particularly with
respect to processing aids (e.g. enzymes), and that furthermore where
necessary, these gaps woud be filled by proposals for additional legislation.
As
a result, the Commission added the following statement to the Novel
Food Regulation: "The Commission confirms that should it appear
in the light of experience, that there are gaps in the system of
protection of the public health provided for by the existing legal
framework, in particular in respect of processing aids, it will
formulate appropriate proposals in order to fill those gaps."
In
an attempt to include gmo enzymes when used as processing aids into
the scope of the EU Novel Food Regulation, the Dutch authorities in
July 1997 wrote a proposal to regard enzymes that are not removed
from the final food as ingredients instead of processing aids. In
this way, such gmo enzymes would be covered by the EU Novel Food
Regulation. Due to strong opposition of the French authorities, the
Dutch proposal has not been accepted. Instead, the European
Commission was asked by the Member States to prepare a paper
regarding the present legal situation for food enzymes. The European
Commission transferred this task in October 1998 to a so-called
Scientific Co-operation (SCOOP) task force, in which experts from
various Member States participated. The four objectives for the SCOOP
task force were to:
(i).
Make a list of food enzymes in use in EU;
(ii).
Study the way they have been evaluated for their safety;
(iii).
Make overview of the current legal situation;
(iv).
Find criteria for distinguishing between the use of enzymes as
additives, processing aids or ingredients.
The
SCOOP task force finished its work at the end of 2000. The report
however, has not yet been officially published. One of the main
conclusions the SCOOP task force drew was that the present
definitions on additives and processing aids do not provide
sufficient criteria to distinguish between the use of enzymes as an
additive or as a processing aid. The problem on how to distinguish
between additives and processing aids is now also being discussed at
international level, namely within the Codex Committee for Food
Additives and Contaminants. The results of this discussion, which may
take several years, can potentially have a great impact on the way
enzymes are regulated in future in the European Union and elsewhere.
Recently,
(July 2001), the European Commission adopted two new proposals for
regulating products derived from gmos:
(i).
Proposal for a regulation on genetically modified Food and Feed (15)
(ii).
Proposal for a regulation concerning traceability and labelling of
gmos and traceability of food and feed products produced from gmos (16)
Before
becoming law, the proposals will first have to be accepted by the
European Council and Parliament, a process which make take several
years. The proposals will replace the above mentioned EU Novel Food
Regulation as far as products derived from genetic modification are
concerned. Again, enzymes when used as processing aids in food are
explicitly exempted from the proposals. Whether this will again lead
to discussions within the European Parliament remains to be seen. |
