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Udvalget for Fødevarer, Landbrug og Fiskeri 2007-08 (2. samling)
KOM (2007) 0872 Bilag 3
Offentligt

Fødevarestyrelsen

[email protected]

31. januar 2008

Sofie Krogh Holm

Dok. 56786/ps

Nye fødevarer (novel food)

Fødevarestyrelsen har den 21. januar 2008 (j.nr.: 2008-20-221-02835/HBO) sendt

forslag til Europa-Parlamentets og Rådets forordning om nye fødevarer og om

ændring af forordning (EF) nr. XXX/XXXX [fælles procedure] i høring.

Forbrugerrådet har følgende kommentarer (på engelsk):

Generally, too many definitions are lacking. Instead the document will need several

explanatory documents which the Commission will have to write. The explanatory

documents will be regarded as "technical documents", which means that the

Commission can act without officially involving parliament/stakeholders - this is

unacceptable.

Main points:



Keep medicine and food separate.

Products which are only fit for a very

small part of the population should NOT be accepted as food, but as medicine



Daily intakes should be co-ordinated and distributed into food groups like

additives



The boundary between novel foods and additives needs further clarification



The common procedure should be known before accepting the revised

novel food



Nano food needs specific nano risk assessment



Approval of cloned animals must include a system of traceability

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Scope (Article 2):

Before the application is accepted as a novel food application,

there should be a procedure where it is decided by EMEA (European Medicines

Agency) (and NOT the procedure mentioned in Article 2, 3) whether the food is

actually a food or indeed a medicine according to 65/65/EEC and 92/73/EEC.

It is not clear whether fibres are falling into the novel food regulation or the

regulation for vitamins and minerals 89/398 2002/46/EC. There is a need for a

definition of fibre. In case of a new fibre the procedure should be to get novel food

approval first and thereafter a registration under the vitamin and mineral

legislation.

There should be a set of criteria for determining what is an additive and what is

not. As food producers do not want to use E numbers (they think consumers will

not accept it), they try to circumvent legislation by registering as novel food. For

example Lucopene (additive E160d) has also been approved as a novel food under

2006/721/EC. The approval does not allow the use of lucopene as a food colour -

but how should this be assessed in practice?

Alfa-cyclodextrin is in the process of being approved as a novel food. At the same

time beta-cyclodextrin (E459) is accepted as an additive, and gamma cyclodextrin

was refused a novel food approval, because beta cyclodextrin is an additive. Again

it is difficult to see a clear line between additives and novel food.

This might have a major impact on future additives, as they all might seek approval

under the novel food legislation by downplaying technical purposes and focusing

on health benefits (the two examples mentioned above)

Definitions (Article 3):

The definition of “nano” should be much more detailed – in order to assure that all

nano food is included. Further it should be stressed that the method for risk

assessment of nano food and nano ingredients should be specifically designed for

nano characteristics.

As also mentioned under (6) and article 3, 2 a) ii), offspring of clones is not seen as

novel food, only the clones themselves. In reality this means that there will be no

further safety evaluation or registration of meat, milk and eggs derived from

offspring of clones. We think that it makes sense to approve the cloned animal, but

with the novel food approval traceability of off-spring and products thereof should

be guaranteed.

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Food with a new or intentionally modified primary structure and food consisting of

or isolated from micro-organisms, fungi and algea should

always

be considered

novel food.

Specific legislation does exist for genetically modified cultures and for cultures for

infant and follow-on formulae. For probiotic cultures for animal feed completely

harmonised and very detailed EU legislation has existed since 1994. Thus, for the

time being there is no regulation on cultures in food.

There is a lack of regulation on micro-organisms. They should undergo a novel

food approval, because the amounts (concentration into single cultures) and

specifications they are used in today differ from traditional food.

A risk assessment specific for micro-organisms at strain level should be carried

out. For example

enterococcus faecalis

is used as a probiotic, but is also being

associated with endocarditis, bacteraemia, intra-abdominal, urinary tract and

central nervous system infections in hospitals

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.

Developments in biotechnology are also making it possible to add cultures to food

which produce for example the bacteriocin Nicin. Nicin is a food additive, but

when the culture is added, the additive legislation is circumvented. In the future we

might see more cases of cultures being added to circumvent additive regulation.

This clearly demonstrates the need for regulation of the new use of micro-

organisms (the new being the concentration of micro-organisms into pure cultures).

Micro-organisms should be approved at

strain

level, because it is at strain level

that the specific characteristics are found.

Traditional foods on the fast track: novel foods which are approved under the fast

track model should be time-limited (e.g. 5 years). During this period they should be

monitored and thereafter re-evaluated for a full novel food approval.

1

S. Wessels et al.:” The lactic acid bacteria, the food chain, and their regulation”. Trends in Food

Science & Technology 15 (2004) 498–505

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Use of food for human consumption before 15/5 1997 (Article 4)

Food that has not been used for human consumption to a significant degree:

according to (29) and article 4. 2. the Commission shall establish the criteria under

which foods may be considered as having been used for human consumption to a

significant degree within the community before 15 May 1997. We cannot support

this, but think that the criteria should be part of article 3 in this revised regulation.

Conditions for inclusion into Community list (Article 6)

The food can only be included in the Community list if it does not pose a safety

concern to health.

To this article should be added that the food should be safe for

all

consumer

groups. We

do not

want marketing of foods like phytosterols which according to

EC no

608/2004 have to have a statement that reads:

1. “the product may not be nutritionally appropriate for pregnant and

breastfeeding women and children under the age of five years”

2. “there shall be a statement that the product is intended exclusively for

people who want to lower their blood cholesterol level”

3. “there shall be a statement that patients on cholesterol lowering medication

should only consume the product under medical supervision”

This fact should be underlined by the German phytosterol report (VZBV) and the

Danish Consumer Council’s analysis report where it is clearly illustrated that

everyday food is not separated. Once it is in a household all members of the

household will consume it. Food that is targeted at very specific groups and not fit

for the majority should be a medicine.

There should also be a public list of foods/food ingredients that applied for novel

food and did not pass the risk assessment or was withdrawn for other reasons. This

is a matter of transparency. Industry was against this point for the additive

regulation. For NGOs it is a good tool, for example when comparing risk

assessments between EU and third countries.

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Content of Community list (article 7)

It is very difficult to comment since the procedure is not laid down yet (4-pack).

The information given in the Community list should be the same as EC 1852/2001:

”(a) Name and address of the applicant;

(b) Description allowing the identification of the food or food ingredient;

(c) Intended use of the food or food ingredient;

(d) Summary of the dossier, except for those parts for which the confidential

character has been determined in accordance with Article 1(3);

(e) Date of receipt of a complete request.”

Further we should ask for a re-evaluation after 5-10 years.

Novel food ingredients should get approved in certain food categories and at

different concentration (in case it is an ingredient). ADIs (acceptable daily intake)

should not be given to a single company. In case of phytosterols other companies

have applied for different uses later on – so there is a risk of over-dosing.

Traditional food from a third country (article 8)

There is a need for a clear set of criteria. The quality of data should be defined,

dietary exposure should be assessed. The fast track procedure should result in time-

limited approvals and re-evaluation hereafter. It is not acceptable that Member

States will have to proof (with scientific evidence) that something is unsafe

(“reversal of the burden of proof”) while the food business operator planning to

bring this food on the EU market only has to show a "safe history of use as food in

a 3rd country". Especially as there are no criteria listed within the regulation on

how to demonstrate a safe history.

Obligations on the food business operators (article 11)

An article should be added which states that food businesses must pay a fee in

order to have their application processed. EC 178/2002 (57) is mentioning this

possibility.

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Post-market monitoring: the post-market monitoring should be long-term post-

market monitored. Reviewed every 5 years. Post-market monitoring should be

paid

for by the business but

conducted

by national authorities, an independent risk

assessment institute or EFSA.

Data protection (article 12)

It should be stated that toxicological data cannot be protected.

Med venlig hilsen

Mette Boye

Chef for Forbrugerpolitisk Center

Sofie Krogh Holm

Fødevarepolitisk medarbejder

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