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Peer-reviewed | Manuscript received: May 19, 2017 | Revision accepted: August 04, 2017
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for the development of innovative tural or legal person.1 According to the market because of protection
health-related products as is practiced Article 3 (2) of the Regulation (EC) against fraud [8]. This includes e.g.
at the nutriCARD competence cluster. 178/2002, a food business is any nauseating foods (like the accepted
Here the possibility of the new pro- undertaking involving the produc- case of ‘a hair in one’s soup’) or
duct being a medicinal product must tion, processing and distribution of unhygienic food production condi-
first be ruled out; to this end, the Ger- food, “whether for profit or not and tions (see Section 40 Para. 1 of the
man Act on Medicinal Products (“Arz- whether public or private” [7]. This LFGB). This should be distinguished
neimittelgesetz” [AMG]) [9] must be is therefore also relevant for product from subjective feelings of disgust,
consulted. Section 2 (1) of the AMG developers, who e.g. offer sample such as when eating algae or insects
distinguishes between so-called func- testing at trade fairs. (even if there are numerous ex-
tional medicinal products (“Funktions- What does ‘safe’ mean in this con- amples of their consumption).
arzneimittel”), which influence physio- text? According to Article 14 of For example, the use of the colour-
logical functions, and presentational Regulation (EC) 178/2002, a food ing agent E120 (cochineal or car-
medicinal products (“Präsentations- must not be “injurious to health” mine), which uses extracted insect
arzneimittel”), which have characteri- (i.e. it must not contain ingredients compounds, is common in yoghurt
stics that are supposedly suitable for that may harm a person’s health) desserts, jams and sausage products.
the healing, alleviation or prevention or “unfit for human consumption” Special attention should be paid to
of diseases or pathological symptoms. (e.g. foul). In this context, howe- names and labelling of non-pre-
In the latter case, a claimed effect is ver, it is important to consider the packed foods (e.g. in restaurants,
sufficient to fulfil this criterion, mean- “normal conditions of use” – and, canteens and bakeries), because a
ing the effect does not need to be pro- therefore, normal consumption as complete list of ingredients is not
ven. opposed to excessive consumption, mandatory for non-pre-packed
The practical relevance of the clari- which applies in the case of things foods under Article 44 of the re-
fication of this issue is high – if a like sweets. Under Article 14 (4) of gulation on the provision of food
supposed food is in fact found by Regulation (EC) 178/2002, the rele- information (“Lebensmittelinfor-
a court to be a medicinal product, vant criteria for the injuriousness of mationsverordnung”, LMIV) [11]
then this product will be deemed food include cumulative toxic effects and the national regulation on de-
an unauthorized medicinal product and particular health sensitivities of signation (LMIV AV), with further
that has been placed on the market. a specific category of consumers. details which took effect on 13 July
Case example: For example, this Especially in the field of product of this year [12]. It should therefore
was the case in a verdict by the innovations with health benefits, it be critically determined whether
German Federal Court of Justice is important that the levels of vita- any small amounts of insect protein
in 2010, where a drink containing mins, minerals or secondary plant (compared to other, more quantita-
gingko that was freely on sale, was compounds that are injurious to he- tively significant ingredients) in e.g.
classified as a medicinal product alth according to Article 14 are not a ‘green spelt burger’ should be an-
[10]. According to Section 17 of the exceeded. nounced in a company canteen.
AMG, infringements against the act Among other factors, whether a
can result in prison sentences or food is unfit for human consump-
Hygiene and HACCP
fines. tion depends, according to Article 14
(5) of Regulation (EC) 178/2002, on Food safety is closely connected to
foulness and/or contamination that hygienic production conditions. Va-
Food safety
have rendered the food unacceptable rious European and national laws
Moreover, according to Article 14 of – even if this has no negative effect and regulations regulate adherence
Regulation (EC) 178/2002, only safe on health. to hygienic standards. A central
foods may be “placed on the mar- role is occupied by Regulation (EC)
ket” and according to Section 5 (1) Nauseating food – a reason for
of the LFGB only safe foods may be complaint?
produced (for others) [8]. The food
business operator is responsible for German national law goes even
meeting food legislation require- further in these restrictions, ad-
ments, including those pertaining ding in Section 11 Para. 2 No. 1 1
According to Section 1 of the German Civil
Code (BGB), humans have legal capacity by
to food safety, according to Article of the LFGB that foods other than
birth. This is the meaning of the term ‘natural
17 (1) in conjunction with Article those mentioned in Regulation (EC) person’. In contrast, legal persons are legal en-
3 of Regulation (EC) 178/2002, no 178/2002 that are “unfit for human tities such as corporate bodies, companies and
matter whether the operator is a na- consumption” may not be placed on associations, and they also have legal capacity.
852/2004 [13]. Pursuant to Article requirements set out in Article 3 of 1 January 2018. The EFSA will
5 of this regulation, every food busi- this regulation, a new food product provide scientific assessment. If an
ness operator is obligated to install, must not “present a danger for the examination is successful, the Com-
perform and maintain one or more consumer” or “mislead the consu- mission will trigger an update of the
procedures based on the norms of mer” [17]. Pursuant to Article 1 of so-called Union list. This Union list
“Hazard Analysis and Critical Con- Regulation (EC) 258/97, this applies contains all approved novel food ap-
trol Points” (HACCP). To this end, at to “novel foods or novel food ingre- plications.
first there is an analysis of potential dients” which had not been consu- A different approval procedure is
health risks in the process. On this med in the European Union “to a planned in the case of traditional
basis, critical control points (e.g. the significant amount” up to 15 May food that has been consumed in a
temperature of warm meals) are 1997. Under Article 1 Para. 2 letter third country outside of the Euro-
determined, limits are defined and f, this may also apply to foods and pean Union to a significant amount
measures for monitoring, correc- food ingredients “to which has been before 15 May 1997. The applicant
tion, verification and documentation applied a production process not will have to prove that the new
must be set. This is obligatory, no currently used”. The following ex- food had been used by a signifi-
matter the company’s size – and it amples illustrate how this sentence cant number of people in a non-EU
also applies to product developers may be interpreted. country for at least 25 years. This
who place food on the market, e.g. Case example: Despite the fact that could apply to foods like stevia or
in the context of testing at fairs. rape has been well known and in use chia seeds, which have not been ex-
Furthermore, there are national for the production of food in Europe amined by the new simplified proce-
regulations but also non-binding for a long time, an isolate of rape dure so far. While the EFSA is gran-
norms of the German Institute for seed protein had to be authorized as ted nine months for the approval
Standardization (“DIN-Normen”, a novel food [18]. The same applied procedure of non-traditional foods
e.g. for training courses in hygiene to a baking yeast which contained and the Commission has seven
[14]) and industry guidelines (e.g. more vitamin D than conventio- months to publish the results, these
on hygienic practices, “Leitlinien für nal baking yeast due to a so-called timeframes are shortened for tradi-
eine gute Hygienepraxis” [15]) that bio-addition technique (in this case tional foods to six and three months
are considered in practice and should exposure of the yeast to UV light) (approval procedure and publication
be maintained. [19]. respectively). In contrast to the for-
mer Regulation (EC) 258/97, the
Companies’ own internal hygienic The amendment of the novel new Regulation (EU) 2015/2283 ex-
standards should also be considered food regulation, Regulation (EU) plicitly names insects and any pro-
when developing new products: It 2015/2283 [20], which provides ducts derived from insects as well as
should be ensured that a product some changes to the old regulation, food consisting of “engineered nano-
intended for use in gastronomy took effect on 31 December 2015 materials” as novel food.
complies with the standards in this and will be binding from 1 January A novel food application involves
sector. For examples, eggs are often 2018. Important topics addressed considerable effort in terms of time
only used when already processed by the new regulation are the cen- and financial resources. It should
by heating (e.g. as ‘long eggs’) or tralized approval procedure by the therefore be evaluated beforehand
with a pasteurized egg shell in order European Commission and the Eu- whether a product innovation is
to fulfil the requirements of Sec- ropean Food Safety Agency (EFSA) classified as a novel food under the
tion 20a of the national regulation and the simplified authorization of regulation.
on the hygiene of animal products traditional foods from non-member
(“Tierische Lebensmittel-Hygiene- countries as novel foods. While until
Additives and food fortification
verordnung”, Tier-LMHV) on mi- now the national institutions have
nimizing the risk of salmonella for been responsible for the examination Additions play another major role
consumers [16]. and authorization of novel food ap- in product innovations. This area
plications – in Germany this is the is covered by the regulation for ad-
Federal Office of Consumer Protec- dition, Regulation (EC) 1925/2006
Innovation = novel food?
tion and Food Safety (BVL) until 31 [21]. It regulates the addition of mi-
Another important regulation in December – the European Commis- nerals, vitamins and “certain other
the context of product development sion is intended to be the central ex- substances” to foods (while accor-
is Regulation (EC) 258/97 concer- amination and approval authority ding to Article 1 [3] there are also
ning novel foods [17]. Among other for novel food applications from specific other regulations that apply,
Science & Research | Overview written permission of Umschau Zeitschriftenverlag GmbH, Wiesbaden.
e.g. for novel foods and additives); are treated on a par with additives. pursuant to Article 44 LMIV, there
a so-called positive list names these This could mean that they have to is no European legal foundation for
substances. According to Article 3 be approved separately, and as such non-pre-packed foods. Yet pursuant
of Regulation (EC) 1925/2006, such this matter should be examined by to that same Article 44, the indivi-
additions may even take place when the food business operator. How- dual member states may formulate
the added substance is not usually ever, this equal treatment under Sec- national rules for declaration. This
contained in the food. They may in tion 2 Para. 3 of the LFGB has been is the reason why the German re-
particular be added “in order to take the subject of considerable contro- gulation on the approval of additi-
into account” the fact that e.g. a de- versy in legal contexts and does not ves (“Zusatzstoff-Zulassungs-VO”,
ficiency exists, to improve the nutri- apply in full, e.g. for amino acids ac- ZZulV) [29] plays an important
tional status of population groups, cording to a verdict of the European role, as this regulation states more
or to correct possible deficiencies in Court of Justice [24]. Furthermore, concrete rules for declaration in Sec-
the future. According to Article 4 in the context of the addition of vi- tion 9. It states that some additives,
of the regulation, however, the ad- tamins and minerals it is import- including coloring agents, must be
dition to unprocessed foods is not ant to consider that a food must be labelled; pursuant to Section 9 Para.
permitted. This is of significance for safe and that the line between food 6 No. 5 and No. 6 of the ZZulV, this
labelling in particular. and medicinal product must not be also applies to menus in restaurants
Case example: If an egg for ex- crossed. A product developer should and the public catering sector. This
ample is fortified with vitamins, it therefore check the amount of added is due to protection against fraud,
becomes a processed food (an egg ingredients in this respect. and not for health reasons. Never-
product) with a corresponding list of theless, consumers are sceptical
ingredients and is no longer an un- What needs to be considered with towards this topic. According to a
processed egg. On the other hand, an regard to the technological addi- survey, approximately 80% think
egg that contains a higher amount tion of enzymes, flavoring agents that a food should contain as few
of certain substances (e.g. vitamin and additives, is settled for the EU additives as possible [30]. A pro-
D) than conventional eggs due to by the “Food Improvement Agents duct developer should therefore try
a so-called bio-addition technique, Package” (FIAP), which includes a to limit the usage of additives to a
is not covered by Regulation (EC) corresponding regulation with basic minimum. This also applies to the
1925/2006 and does not count as a provisions such as standardized additives which must be declared in
processed food [22]. evaluation and approval processes menus and public catering, if the
[25]. A so-called “Verbot mit Erlaub- respective food is to be used in this
Furthermore, alcoholic drinks with nisvorbehalt”, a prohibition with a sector.
more than 1.2 vol.% are not usually chance of separate approval under
allowed to be fortified. According to certain circumstances, applies here.
Articles 6 and 14, this regulation This means that all flavoring agents,
Product labelling
is actually supposed to limit the enzymes and additives are generally
and misleading
maximum amounts of additions, prohibited, unless their use is per-
although no such amounts have mitted for certain conditions. The In addition to their formal product
been stated thus far. As such, pro- three other regulations of the FIAP designation, foods may also carry
duct developers are required to check [26–28] contain, inter alia, terms other invented names under Article
whether a certain ingredient is sub- of usage and regulation exceptions. 9 Para. 1 letter a in conjunction with
ject to restrictions under national For example, the carry-over princi- Article 17 of the LMIV. Here, how-
law. Such restrictions would apply ple applies under Article 20 letter b i ever, protection against misleading
until completion of the EU regula- of the LMIV [11], stipulating that and fraud (cf. Article 16 of Regulation
tion. For example, this applies to the additives that come to a product in- [EC] 178/2002 [8], Section 11 of the
German Section 2 (3) of the LFGB [9] directly via another product do not LFGB [9] in conjunction with Article
in conjunction with the German re- have to be labelled if the additive has 7 of the LMIV [11]) and the rules on
gulation on the addition of vitamins no further technical effect. Additives unfair competition (cf. Section 3 of
[23], which regulates and limits the which are used as processing aids the German act on unfair competition,
use of vitamins A and D and their (e.g. gelatine for the clarification UWG [31]) still need to be taken into
derivates more precisely. According of wine) do not have to be labelled consideration.
to Section 2 (3) of the LFGB, mine- either according to Article 20 Para. b For some food categories, formal de-
rals, trace minerals (except sodium ii of the LMIV [11]. With the excep- signations are strictly regulated – the
chloride), amino acids and their de- tion of the allergens specified in Ar- German regulation on milk products
rivates as well as vitamins A and D ticle 9 Para. 1 letter c of the LMIV [32] for example declares what cha-
Science & Research | Overview written permission of Umschau Zeitschriftenverlag GmbH, Wiesbaden.
e. V. (BVE). Consumers‘ Choice ’11. Lebens- 35. M intel Global New Products Data- 38. Käseverordnung (KäseV), Ausfertigungsda-
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Aufl. (2015) Zugriff 27.04.17 39. Verbraucherschutzministerkonferenz. Proto-
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(UWG), Ausfertigungsdatum: 03.07.2004, C-422/16 „Vorlage zur Vorabentschei- 12. VSMK am 22. April 2016 in Düssel-
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17.02.2016 landwirtschaftliche Erzeugnisse – Verord- terkonferenz.de/documents/TOP20_Defi
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zeugnisverordnung -MilchErzV), Ausferti- Anhang VII Teil III – Beschluss 2010/791/ 21.04.17
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der Ernährungs- und Landwirtschaftsorga- ropäischen Parlaments und des Rates vom
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ganisation (WHO) der Vereinten Nationen. Marktorganisation für landwirtschaftliche
Codex Alimentarius Erzeugnisse
DOI: 10.4455/eu.2017.042