Download DRAFT Order on the addition of specific substances other than

DRAFT
Order on the addition of specific substances other than vitamins and minerals to food
1)
In pursuance of Articles 7-9, Article 37 and Article 60 Paragraph 3, of Act No. 526 of 24 June 2005 on food, the following is set:
Area of application and definitions
Article 1. This Order relates to the addition to food, including food supplements, of the following substances:
substances that are not vitamins or minerals and which have a nutritional or physiological effect, and
flavourings and food additives which, in addition to being added as flavouring or food additive, also have a nutritional or
physiological effect.
Paragraph 2. This Order only applies where no specific regulations have been set relating to:
1)
nutrients
2)
new foods and new food ingredients (novel food)
3)
food for particular nutritional uses
4)
food additives
5)
flavourings
6)
genetically modified food
7)
marketing standards and product standards.
Paragraph 3. This Order doe not apply to:
1)
plant material in fresh, dried, chopped, sliced or pulverised form, and
2)
extracts of plant material which are only derived by simple aqueous extraction followed, where appropriate, by dehydration.
1)
2)
Article 2. The following definitions apply in this Order:
‘Substances’: Substances which have a nutritional or physiological effect and which
a)
are not vitamins or minerals,
b)
are added to food with the purpose of achieving a nutritional or physiological effect,
c)
have a purity of minimum 50 % or are concentrated 40 times or more, and
d)
normally are not ingested as a food in itself and normally are not used as a typical ingredient in food.
2)
‘Flavouring’: Flavouring substance, flavouring preparation, process flavouring, smoke flavouring, smoke flavouring substance or
mixtures of these or mixtures of these with other additives or food.
3)
‘Aromatised drinks’: Non-alcoholic drinks to which flavouring ingredients or substances are added.
4)
‘Sports products’: Food for intake in association with highly demanding muscular work, particularly for sportspeople, as included
by the Order on particular nutritional use.
5)
‘Food additive’: Reference is made to the definition in Regulation (EC) No. 1333/2008 of the European Parliament and of the
Council of 16 December 2008 on food additives.
1)
Conditions for use
Article 3. Only the substances included by the Order which are specified in Annex 1, are to be added to food, including food
supplements and under the conditions set in the Annex, cf. however Paragraph 2.
Paragraph 2. The maximum amount set in the Annex must not be exceeded, regardless of the source of the substance or the purpose
of the addition, unless otherwise specified for the substance.
Paragraph 3. Substances included in Paragraph 1, are to comply with the requirements relating to identity and purity set in the
specifications in Annex 2.
Article 4. Substances which are included in Annex 1 and which are required to be added to food under conditions that are other than
those specified in the Annex, can be brought into use 6 months after the addition of the substance is reported to The Danish Veterinary
and Food Administration.
Paragraph 2. The notification, cf. Paragraph 1, is to contain the information specified in Annex 3, Section I. The notification relates to
the addition of the specific substance to the specific product. A notification is considered to only have been submitted when all the
required information has been submitted to The Danish Veterinary and Food Administration.
Paragraph 3. Substances which have been submitted to, and subsequently evaluated and approved in another Member State and
where this evaluation has been submitted to The Danish Veterinary and Food Administration can, if one of the substances specified in
Paragraph 1, be brought into use 3 months after they are reported to The Danish Veterinary and Food Administration, cf. however
Paragraph 4.
Paragraph 4. The Danish Veterinary and Food Administration can, where a substantiated need for this is shown to exist, extend the
deadline stipulated in Paragraph 3 to 6 months.
Paragraph 5. A condition for application in accordance with Paragraphs 1-4 is that The Danish Veterinary and Food Administration has
not previously imposed a prohibition against the notified use of the substance.
Paragraph 6. The Danish Veterinary and Food Administration, irrespective of whether or not it imposed, in association with
notification, a prohibition against a substance included in Paragraph 1, can impose a prohibition against the use at a later point of time,
if conditions indicate this is necessary.
Paragraph 7. The Danish Veterinary and Food Administration can set conditions for the use of a substance, including that the use is
only permitted for a limited period of time or that the substance is only permitted to be used in specific product groups.
Paragraph 8. A notified substance must only be used in the way stipulated in the notification.
1)
The draft Order has been notified in accordance with the European Parliament and Council Directive 98/34/EC (the
information procedure directive), last amended by Directive 98/48/EC.
Article 5. The provisions in Article 4 similarly apply to amino acids that are not included in Annex 1, but which comply with the
requirements relating to identity and purity set in the specifications in Annex 2.
Article 6. The addition of substances that are not included in Article 5 or Annex 1, is to be approved by The Danish Veterinary and
Food Administration.
Paragraph 2. The application for approval, cf. Paragraph 1, is to contain the information specified in Annex 3, Section II. An
application is considered to only have been submitted when all the required information has been submitted to The Danish Veterinary
and Food Administration.
Paragraph 3. The Danish Veterinary and Food Administration can set conditions for the use of a substance, including that the use is
only permitted for a limited period of time or that the substance is only permitted to be used in specific product groups.
Paragraph 4. The Danish Veterinary and Food Administration is to make a decision with respect to an application for approval at the
latest 6 months after receiving the application, however at the latest 3 months after receipt if the submitted data has been previously
approved in another Member State, cf. however Paragraph 5.
Paragraph 5. The Danish Veterinary and Food Administration can, where a substantiated need for this is shown to exist, extend the
deadline stipulated in Paragraph 4 to 6 months.
Article 7. The producer, the importer or other party responsible for the first marketing in Denmark must, at the latest by the point in
time at which the food to which the substances included in Annex 1 are marketed, submit a sample of the labelling used to the local
regional veterinary and food administration centre.
Paragraph 2. Amendments to the labelling used and withdrawal of the food from the market are to be reported to the local regional
veterinary and food administration centre.
Paragraph 3. Paragraph 1 and 2 do not apply to food supplements.
Article 8. The manufacturer or importer that is responsible for the first marketing in Denmark of a food to which substances have
been added, is to and in addition to the ordinary regulations on self-inspection, comply with the supplementary self-inspection
regulations specified in Annex 4.
Penal sanctions
Article 9. Regulation (EC) No. 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures
relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing
Decision No. 3052/95/EC, applies to the administration of the Order.
Article 10. The Danish Veterinary and Food Administration, immediately after case management is completed, updates Annex 1 and
2 with substances which are
1)
brought into use in accordance with Article 4, Paragraph 1-5, and
2)
approved in accordance with Article 6, Paragraph 1.
Article 11. Those who violate Article 3, Article 4, Paragraph 1, 5 or 8, Article 5, Article 6 Paragraph 1, Article 7 Paragraph 1 or 2, or
Article 8, or conditions set in pursuance of Article 4, Paragraph 7, or Article 6, Paragraph 3, of this Order are penalised by fines.
Paragraph 2. The penalty can increase to imprisonment for up to 2 year if the violation is a result of actions or omissions which were
carried out intentionally or through the exercise of gross negligence, and which, through the violation
1)
harmed health or brought about the risk of this, or
2)
achieved or was intended to achieve a financial benefit for the parties concerned or others.
Paragraph 3. Liability to punishment may be imposed on companies, etc. (legal entities) in accordance with the rules of Chapter 5 of
the Penal Code.
Entry into force
Article 11. The Order comes into force on dd. mm. 2011.
Annex 1
Specific substances, other than vitamins and minerals, which are permitted to be used in food, including in food
supplements
The amounts specified in the Annex must not be exceeded, regardless of the source or the purpose of the addition, unless otherwise
specified for the substance.
Name
1.3-1.6 betaglucan
Gum arabic (acacia
gum)
Conditions for use
Food supplement
Other food categories
Maximum total amount used must not
To be determined.
exceed 200 mg per recommended daily
dose.
Maximum total amount used must not
To be determined.
exceed 1 g per recommended daily
dose.
Choline
To be determined.
Maximum total amount used in
aromatised drinks and in drinks with a
maximum alcohol content of 5 % vol.
must not exceed in total 360 mg/litre.
Creatine
To be determined.
Amount used in pure creatine
monohydrate sports products should not
be less than minimum 2 g and not
exceed maximum 3 g per daily dose.
Docosahexaenoic acid
(DHA)
Maximum total amount used must not
exceed 1,000 mg per recommended
daily dose, however in total maximum
2,560 mg EPA and DHA per
recommended daily dose.
To be determined.
Eicosapentaenoic acid
(EPA)
Maximum total amount used must not
exceed 1,280 mg per recommended
daily dose, however in total maximum
2,560 mg EPA and DHA per
recommended daily dose.
To be determined.
Glucuronolactone
Maximum total amount used must not
exceed 70 mg per recommended daily
dose.
Amount used in aromatised drinks in
total must not exceed a maximum of
2,400 mg/litre.
Inositol
Maximum total amount used must not
exceed 50 mg per recommended daily
dose.
Maximum total amount used in
aromatised drinks and in aromatised
drinks with a maximum alcohol content
of 5 % vol. must not exceed in total 300
mg/litre.
Caffeine
Maximum total amount used must not
exceed 300 mg per recommended daily
dose, distributed across minimum 3
doses.
Amount used in aromatised drinks in
total must not exceed a maximum of
320 mg/litre, originating from all
sources.
Amount used in aromatised drinks with
a maximum alcohol content of 5% vol.,
in total must not exceed a maximum of
150 mg/litre, originating from all
sources.
Lecithin
Maximum total amount used must not
exceed 10 g per recommended daily
dose, distributed across minimum 2
doses.
To be determined.
L-Carnitine
Maximum total amount used must not
exceed 2 g per recommended daily
dose.
To be determined.
L-Carnitine-L-Tartrate
Maximum total amount used must not
exceed 3 g per recommended daily
dose.
Maximum total amount used must not
exceed 6 mg per recommended daily
dose.
To be determined.
L-Lysine
Maximum total amount used must not
exceed 100 mg per recommended daily
dose.
Maximum total amount used in
aromatised drinks and in aromatised
drinks with a maximum alcohol content
of 5 % vol. must not exceed in total 200
mg/litre.
Lutein
Maximum total amount used must not
exceed 20 mg per recommended daily
dose.
Amount used in aromatised drinks in
total must not exceed a maximum of 2
mg/litre.
Lycopene
Maximum total amount used must not
exceed 15 mg per recommended daily
dose.
To be determined.
Taurine
Maximum total amount used must not
exceed 1,000 mg per recommended
daily dose.
Amount used in aromatised drinks in
total must not exceed a maximum of
4,000 mg/litre.
L-Cystine
To be determined.
Maximum total amount used in
aromatised drinks with a maximum
alcohol content of 5 % vol. must not
exceed in total 3.6 mg/litre.
Ubidecarenone
(Coenzyme Q10)
Ubiquinol
Maximum total amount used must not
exceed 180 mg per recommended daily
dose.
Maximum total amount used must not
exceed 50 mg per recommended daily
dose.
To be determined.
To be determined.
Annex 2
Identity, purity and analysis method specifications
Name
Identity and purity specification
Analysis method 1
Amino acids
Glutamic acid
Glycine
L-Alanine
L-Arginine
L-Argininehydrochloride
L-aspartic acid
L-Carnitine
L-Carnitine-L-Tartrate
L-Cysteine
L-Cystine
L-Glutamine
L-Histidine
L-Histidinehydrochloride
L-Isoleucine
L-Leucine
L-Lysine Aspartate
L-Lysine-hydrochloride
E 620 (EU 23)
E 640 (EU07)
DK 119, FCC V p. 18
DK 100, FCC V p. 34
CX 02
FCC V
FCC V
FCC V
p.
p.
p.
p.
695
208
18
34
DK 101, FCC V
DK 120, FCC V
DK 102, FCC V
DK 127
E 920 (EU07)
DK 128, FCC V
DK 121, FCC V
DK 103, FCC V
FCC
FCC
FCC
FCC
FCC
FCC
FCC
FCC
p.
p.
p.
p.
p.
p.
p.
p.
35
41
100
217
130
130
197
217
104,
105,
106,
123,
p. 130
p. 197
p. 217
V
V
V
V
V
V
V
V
FCC V p. 217
FCC V p. 234
FCC V p. 252
JSFA p. 419
FCC V p. 217
FCC V p. 234
FCC V p. 252
JSFA p. 419
DK 107, FCC V p. 257
FCC V p. 257
L-Methionine
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
L-Tryptophan
L-Tyrosine
L-Valine
Other
DK
DK
DK
DK
DK
DK
DK
DK
FCC
FCC
FCC
FCC
FCC
FCC
FCC
FCC
1.3-1.6 betaglucan
Gum arabic (acacia
gum)
Choline
Under preparation
E 414a
Creatine
Docosahexaenoic acid
(DHA)
Glucuronolactone
Inositol
Caffeine
Lecithine
DK
DK
DK
DK
p. 35
p. 41
p. 100
108,
109,
124,
125,
111,
112,
113,
114,
FCC
FCC
FCC
FCC
FCC
FCC
FCC
FCC
V
V
V
V
V
V
V
V
p.
p.
p.
p.
p.
p.
p.
p.
286
330
373
396
474
490
490
492
FCC V p. 228
Ph.Eur.5 p. 1145
CX02 p. 841 and
CX04 p. 65
CX02 p. 963 and
CX11 p. 105
E 160d
DK 110
DK 201, Ph.Eur. 5 p. 2657
1
CX09 p. 49
DK 118, FCC V p. 228
Caffeine – Ph.Eur. 5 p. 1145
E 322b
Lycopene
Taurine
Ubidecarenone
(Coenzyme Q10)
Ubiquinol
c)
286
330
373
396
474
490
490
492
FCC V p. 113
E 161b
b)
p.
p.
p.
p.
p.
p.
p.
p.
Choline chloride – DK 115, FCC V p. 113
Choline citrate – DK 116
Choline hydrogen tartrate – DK 117, FCC V p. 112
Creatine Monohydrate - DK 126
Lutein
a)
V
V
V
V
V
V
V
V
FCC V p. 112
Ph.Eur.5 p. 2657
Under preparation
Commission Directive 98/86/EC of 11 November 1998 amending
Commission Directive 96/77/EC laying down specific purity criteria on food
additives other than colours and sweeteners.
Commission Directive 96/77/EC of 2 December 1996 laying down specific
purity criteria on food additives other than colours and sweeteners
Commission Directive 95/45/EC of 26 July 1995 laying down specific
purity criteria concerning colours for use in foodstuffs.
Newer versions of the analysis method can also be used.
Annex 3
I. Notification, cf. Article 4, Paragraph 2, is to contain the following information:
Enriched food
1.
Notifying party’s name (entity), address, telephone number and e-mail address, where relevant.
2.
Name and address of the producer or, if the producer is not registered in Denmark,
name and address of the importer who is responsible for the first marketing of the product in
Denmark.
3.
The product’s name.
4.
The name of the substances which are notified.
5.
Amount added.
6.
The total amount (any naturally occurring amounts plus additions) in the product of the notified
substances.
7.
The food’s composition in the form of an ingredients list.
8.
The product’s energy content in kJ or kcal.
9.
Whether the notifying party is aware of:
an EU Member State in which this product is already legally marketed, cf. regulation No.
764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures
relating to the application of certain national technical rules to products lawfully marketed in
another Member State and repealing Decision No. 3052/95/EC.
Food supplement
1.
Notifying party’s name (entity), address, telephone number and e-mail address, where relevant.
2.
Name and address of the producer or, if the producer is not registered in Denmark,
name and address of the importer who is responsible for the first marketing of the product in
Denmark.
3.
The product’s name.
4.
The product’s dosage form (tablets, capsules, etc.).
5.
The recommended daily dose.
6.
The name of the substances which are notified.
7.
Amount added.
8.
The total amount (any naturally occurring amounts plus additions) in the product of
the notified substances.
9.
The food’s composition in the form of an ingredients list.
10.
Whether the notifying party is aware of:
an EU Member State in which this product is already legally marketed, cf. regulation No.
764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures
relating to the application of certain national technical rules to products lawfully marketed in
another Member State and repealing Decision No. 3052/95/EC.
Notification is to be sent to:
The Danish Veterinary and Food Administration, for the attention of: The Division for Nutrition, Mørkhøj
Bygade 19, 2860 Søborg, Denmark
II. Application for approval, cf. Article 6, Paragraph 2, is to contain the following information:
Enriched food
1.
The applicant’s name (entity), address, telephone number and e-mail address, where relevant.
2.
3.
Name and address of the producer or, if the producer is not registered in Denmark,
name and address of the importer who is responsible for the first marketing of the product in
Denmark.
The product’s name.
4.
The name of the substances the application relates to.
5.
Amount added.
6.
The total amount (any naturally occurring amounts plus additions) in the product of the
substances which the approval application relates to.
The food’s composition in the form of an ingredients list.
7.
8.
The product’s energy content in kJ or kcal.
9.
Whether the applicant is aware of:
an EU Member State in which this product is already legally marketed, cf. regulation No.
764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures
relating to the application of certain national technical rules to products lawfully marketed in
another Member State and repealing Decision No. 3052/95/EC.
10.
The substance’s chemical name, structural formula and molecular mass.
11.
Specification.
12.
13.
Description of the production process of the substance, in the form of a flow diagram and which
includes information on all raw materials used.
Analysis method for the substance.
14.
Toxicological investigations and evaluations of the substance.
Points 10-13 can be replaced by an identity and purity specification which includes E or DK numbers or by a
specification from an approved body, i.e. European Pharmacopoeia (Ph.Eur.), Food Chemicals Codex (FCC)
or United States Pharmacopeia (USP).
Food supplement
1.
The applicant’s name (entity), address, telephone number and e-mail address, where relevant.
2.
Name and address of the producer or, if the producer is not registered in Denmark,
3.
name and address of the importer who is responsible for the first marketing of the product in
Denmark.
The product’s name.
4.
The product’s dosage form (tablets, capsules, etc.).
5.
The recommended daily dose.
6.
The name of the substances the application relates to.
7.
Amount added.
8.
The total amount (any naturally occurring amounts plus additions) in the product of
substances, which the approval application relates.
9.
The food’s composition in the form of an ingredients list.
10.
Whether the applicant is aware of:
an EU Member State in which this product is already legally marketed, cf. regulation No.
764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures
relating to the application of certain national technical rules to products lawfully marketed in
another Member State and repealing Decision No. 3052/95/EC.
11.
The substance’s chemical name, structural formula and molecular mass.
12.
Specification.
13.
Description of the production process of the substance, in the form of a flow diagram and which
includes information on all raw materials used.
14.
Analysis method for the substance.
15.
Toxicological investigations and evaluations of the substance.
Points 11-14 can be replaced by an identity and purity specification which includes E or DK numbers or by a
specification from an approved body, i.e. European Pharmacopoeia (Ph.Eur.), Food Chemicals Codex (FCC)
or United States Pharmacopeia (USP).
The application is to be sent to:
The Danish Veterinary and Food Administration, for the attention of: The Division for Nutrition, Mørkhøj
Bygade 19, 2860 Søborg, Denmark
Annex 4
Supplementary self-inspection regulations
1)
2)
3)
4)
5)
The entity must be able to document the declared amount of substance added. Samples of the food are to be taken for analytical
checks on the substances added. Self-inspection must be carried out based on the guidelines in Nos 2-3. Analysis of the decay
time in food supplements must in addition be carried out based on the guidelines in No. 4.
The content of each individual substance in food containing up to 5 added substances must be analysed at least once a year. The
content of each individual substance in food containing up to 6-10 added substances must be analysed at least once every other
year. The analyses must be carried out so that an analysis of at least one substance in the product is carried out at least once a
year. The content of each individual substance in food containing more than 10 added substances must be analysed at least once
every third year. The analyses must be carried out so that an analysis of at least one substance in the product is carried out at
least once a year.
If a maximum value for a substance is set in Annex 1, then the analysed content of the substance must not exceed such value.
The decay time of food supplements that are not chewable tablets, effervescent tablets, compressed lozenges, ‘slow-release’
tablets or similar must, in addition to the analysis specified in No. 1, be measured. The decay time must not exceed 60 minutes.
With respect to the import of food from other Member States in the European Community, the analytical check specified in No. 1
can be omitted if the entity can document that a check has been carried out in the notification country, which provides a similar
degree of certainty that this complies with the purpose of the check.