Edition October / 2014
food news
legal and regulatory news
In a decade of an (excessive) information
society this newsletter symbolizes a transfer
of knowledge representing a reduction in
complexity, filtering the flood of information on both, legal and regulatory affairs on
food.
Alfred Hagen Meyer
CONTENT
Hepatitis A in frozen berries in EU - Some
considerations on the “silent” outbreak Austrian Regulation on Allergen Information Classification of plants and plant parts
in foodstuffs - Official Presentation of the
German “List of Substances” Myths and Facts about Innovations
in the Food Sector
Recent decisions of the German
Federal High Court of Justice relating
to Reg. (EC) No 1924/2006
New Law – in headwords & details
Regulatory News
Edition notice 1
5
7
8
10
11
15
19
Hepatitis A in frozen berries in EU Some considerations on the “silent” outbreak
Author: Cesare Varallo I Turin, Italy
On 8th September 2014, the European Food Safety Authority
(EFSA) published the final results of its study on the epidemic of hepatitis A (HAV) that, last year, hit Italy and, to a lesser
extent, several other European countries and that is thought
to have been caused by some mix of frozen berries of EasternEuropean origin.
The study, which has been realized also with the support of the
European Center for Disease Control (ECDC) and of Member States’ experts, has meticulously reconstructed the traceability of
the berries that were considered as potentially carriers of the
infection. However, as will be shown, these efforts have not shed
light on the causes and on the origin of the contamination.
Edition October / 2014
This seems, to say the least, an undesirable conclusion for one
of the biggest and most violent foodborne outbreaks that
Europe has witnessed over the last few years (1.444 cases, of
which nearly 1.300 in Italy). It also leaves us with two unanswered questions:
1) Why was this outbreak almost ignored by media and
risk managers/communicators altogether?
2) Why was it impossible to trace back all the lots involved
and, ultimately, identify the source of the contamination?
By trying to answer these questions, we will also try to
highlight the reasons why this very outbreak should be
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1
considered an important stress test for the European food
safety system as a whole.
Cesare Varallo
Foodlawlatest.com
1. A bit of history
Despite the recent media coverage of this crisis, early warnings of the upcoming epidemic arose between 1st October
2012 and 8th April 2013, resulting in 16 confirmed cases of
HAV infections, with sub genotype IB and identical RNA
sequence, reported in four Nordic countries (Denmark, Finland, Sweden and Norway). EFSA and the ECDC released their
first technical report on 16th April 2013, which helped clarifying the situation: because of the lack of travel history of the
victims outside of the EU, this clearly appeared to be the starting point of a multi-country outbreak, with exposure taking
place solely across the EU territory. The epidemiological studies from the Member States immediately pointed out to frozen berries as carriers of the infection, although the hypothesis had to be fully confirmed at that time.
In the meantime, since 1st January 2013, 15 different laboratories confirmed cases of HAV infection in Germany, the Netherlands and Poland. All ill persons had travelled to the autonomous provinces of Trento and Bolzano, in Northern Italy,
during the exposure period. Over the same period, Italy experienced an abnormal increase in cases of HAV infection both at
local and national levels.
Also in these cases the victims did not have a travel history
outside the EU, whilst the epidemiologists pointed out again
to a possible outbreak involving several Member States,
though plausibly with a common source (i.e. plausibly frozen
berries).
In a technical report dated 28th May 2013, EFSA and ECDC
excluded the existence of a link of this latest outbreak with the
outbreak in the Northern Europe, mainly because the genotype identified was different (IA). Nevertheless, they invited
Member States to raise awareness on a possible increase in
HAV cases associated with ill people with a travel history to
Northern Italy.
On 10th July 2013, EFSA and ECDC published another
update on the outbreak and identified three cases in Ireland
which shared the same sequence as the one of the Italian outbreak and with neither travel history to Italy, nor contact with
other HAV cases. Also in relation to this outbreak, epidemiological, microbiological and environmental investigations indicated again mixed frozen berries as the most likely carrier of the
infection. However, the source of the lots/cases or of the raw
materials could not be identified.
Cesare Varallo is lawyer in Italy and his specialization lies
mainly on food safety, food labeling and food regulatory
issues. He founded the website www.foodlawlatest.com
and in 2013 he started his independent consultancy activity for the food business operators. He can assist clients in the crisis
management and he offers complete
and tailor made support to companies
during food recalls/withdrawals
procedures.
His activity embraces also legal assistance to clients both in managing
consumer’s complaints and in drafting
internal procedures to minimize the
impact of these incidents. He can
represent clients in front of criminal and administrative
Italian courts, and in front of the competition authority
AGCM.
From April 2014 he is Vice President Business and Regulatory Affairs EU at Inscatech, a US based company which,
due to its one of a kind approach, is establishing new
standards in the fight against food frauds. Inscatech, indeed, is well recognized in the GFSI (Global Food Safety Initiative) as provider of food fraud intelligence, forensically
based vulnerability assessments, and validated supply
chain mapping.
He is involved in several teaching and scientific activities,
both for private companies and for public institutions,
especially regarding food safety. He writes regularly on
several Italian and international reviews (i.e.
Alimenti&Bevande, Foodservice Consultant) and is now
working on a book about the RASFF (Rapid Alert System
for Food and Feed), which is expected to be published in
2015.
He is member of the AIDA-IFLA (Italian Food Law Association) and of the AIBADA (Asociación Iberoamericana para
el Derecho Alimentario).
Cesare Varallo
Corso Vittorio Emanuele II, 27 – 10125 – Turin, Italy
Mail: [email protected]
Phone: +39.349.5275567
www.foodlawlatest.com
At the same time, outside the EU, namely in the US, another
outbreak of Hepatitis A was being investigated. The latter,
however, eventually turned out not to be related to the main
Edition October / 2014
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2
one (in 2013, more than 150 people in the U.S. fell ill with
Hepatitis A linked to frozen berry mix processed by Townsend
Farms and sold at Costco and Harris Teeter stores. The source
of that contamination was ultimately traced back to pomegranate seeds from Turkey).
The main epidemic was at its starting point.
2. What to do now?
The genotype identified in the Italian/Irish outbreak (IA) was
different from the one found in the Nordic countries (IB) [in
the end the source was identified in imported frozen strawberries] and also from the pathogen source of a third small
HAV outbreak, caused by travelers returning from Egypt.
Against this background, the simultaneous presence of four
different HAV epidemics should have triggered a more structured and comprehensive reaction from both risk managers
and food business operators.
If on the one hand EU and national authorities responsible for
risk communication failed precisely in communicating adequately the risk, on the other, most of the companies involved
in the commercialization of frozen berries did not run any
reinforced sampling plan for HAV. Indeed, it appeared that
HVA was not a risk systematically contemplated by the HACCP
plans of the major food companies in the frozen sector. Overall, it can be said that the lack of data did contribute to the
spreading of the epidemics besides rendering the withdrawal
from the market of contaminated lots particularly difficult.
Moreover, when official controls started, most of the food
business operators selling frozen berries were already involved
in criminal proceedings for the marketing of food injurious to
health, or had already been subject to administrative sanctions, and did not have analysis performed in the context of
own controls to challenge the public laboratories results.
Foodlawlatest.com
Foodlawlatest.com is the growing blog about food safety
and regulatory issues. Founded
by Cesare Varallo in August 2012,
in two years of activity it changed the way to communicate in
this sector, giving high quality
and accessible information to
food business operators, food
professionals, consultants and
consumers.
Now the website is a well-established platform, and you
can find its daily updates on internet and on all the main
social networks. From 2014 Cesare Varallo started also distributing a professional newsletter of legislative update on
European and Italian food law and regulations, which
comprises also the main weekly news from the food sector, the scientific opinions of the European Food Safety
Authority (EFSA) and the main decisions of the European
Court of Justice. Every new text is completed by an abstract and the service can be personalized on the client
needs, choosing the sectors of interest.
Foodlawlatest.com is starting now offering tailor made
trainings via distance learning and the new service will be
fully operative in 2015.
Clearer and more comprehensive information, including the
potential source of contamination, the products involved and
the possible presence of berries also in cakes and desserts was
what consumers needed to know. Conversely, when specialized press started covering the epidemic in 2014, the real situation was that most of the Italian consumers were not even
aware of the problem.
If there is an understandable caution by the public authorities
in communicating the risk - especially following the E.Coli criIt is also worth mentioning that, on 17th May 2013, the Eurosis in 2011 when Spanish cucumbers were mistakenly indicapean Commission circulated through the Rapid Alert System
ted as source of the outbreak, with massive economic losses
for Food and Fee (RASFF) the very first notification on HVA. The for the sector and panic amongst consumers – the lack of
notification originated from Italy (alert n. 2013.0694), and
communication is simply not a viable option nowadays. Ironiconcerned a frozen berry mix, with raw materials from uncer- cally, health authorities and teams responsible for crisis
tain and different sources (Bulgaria, Canada, Poland and
management seem to lack technical experts in this field. This
Serbia).
is clearly something that needs to be changed.
Despite the RASFF notification notified by Italy in May 2013,
the first epidemiological bulletin from the Italian competent
authorities was published only in November 2013. The bulletin
was, in essence, a technical paper, which did not give any concrete indication to consumers, with the exception of the
advice to boil the berries for at least two minutes, and which
was not adequately promoted or disseminated.
Edition October / 2014
To use a motto that is very familiar to our US colleagues, “communicate truly, communicate in a transparent way and communicate first” (and preferably, we could add, before media
speculation starts) should be the main driver for the food safety authorities involved in the risk management and communication process.
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3. The spreading of the epidemics
In spite of these latest developments, the Italian competent
authorities maintains its line of communication, reiterating the
From May 2013 onwards other cases from the same pathoge- message that the safest way to consume frozen berries is to
nic strain had been reported from Denmark, Finland, France,
boil them for at least two minutes. It also considers that the
Germany, Ireland, Norway, Netherlands, Poland, Sweden and
data on HAV cases recorded in Italy by 31st May 2014 would
the UK (331 in total). HAV was detected in frozen berries mixed confirm the reduction in the number of cases which was
(14 lots) and cakes/pastries with mixed berries (2 lots) in Italy,
already apparent as of November 2013, with the epidemic
France and Norway.
peak located between April and May 2013.
This year the RASFF notifications continued and the final
count was of 2 information for attention and 11 alert notifications. EFSA released an outbreak update on 25th April 2014,
but the cause and the source of the contamination were still
not clear: then, in such situation, most of the food business
operators involved - despite the assurances of their suppliers decided to stop the commercialization of frozen berry mix or
cake/pastries containing raw berries as an ingredient. In Italy,
several criminal proceedings for marketing food injurious to
health are currently ongoing.
In light of the situation above described, the final outcome of
EFSA’s investigation – published on 8th September 2014 - was
very much awaited.
The extent of the final report is really impressive, as well as the
epidemiologic work and the trace-back exercise. The Member
States involved as potential source of the outbreaks cooperated in an admirable way and especially Poland stood out for
having in place a highly effective system for traceability and
official controls.
In any event, despite the epidemic being quite certainly in
decline, it would be prudent at this stage to ensure a minimum level of surveillance on the berries coming from concerned Member States or imported from non-EU countries. If the
level awareness of the issue amongst food business operators
is now certainly higher, the lack of identification of the source
of contamination does not constitute a guarantee that, in
future, the problem will not arise again.
4. Final remarks
Finally, trying to answer to the two questions raised at the
beginning, the HVA outbreak could be defined “silent” for several concurring factors:
- the lack of appropriate communication from risk managers;
- the scarce media interest and coverage due, most likely, to
the low mortality rate provoked by the infection, the technical
The analysis performed in the study of traceability started with complexity of the issue and the relatively low impact on the
38 lots/cases from Italy, Ireland and the Netherlands, then
consumers in terms of food recalls performed (in the end, the
extended to further 5 lots/cases from France, Norway and Swe- overall number of lots/cases identified was 16);
den and examined 6,227 transactions between 1,974 firms.
- the possible high rate of unreported cases and the difficulThe task was huge, but with the help of an open-source softties to link the disease to the foodstuff.
ware developed by the Federal Institute for Risk Assessment
(BfR) in Germany, called “FoodChain-Lab”, was successfully
Moreover, the outcome of EFSA’s investigation provides some
accomplished, despite some unclear spots in Bulgaria.
food for thought for the EU policy-makers and risk managers,
namely:
The investigations, as well as RASFF information and traceability data, suggested with reasonable certainty that Bulgarian
- early warnings of epidemics should never be ignored;
blackberry and Polish redcurrants were the most common
ingredients in lots/cases tracked. Nonetheless, since Poland is - after the E.Coli crisis in 2011 (but also in light of similar cases
the largest producer of redcurrant in Europe and Bulgaria is a
in the US) this outbreak proves again the prominent role of
major exporter of frozen blackberries, it was not possible to
food of non-animal origin in the global food safety scenario; as
identify a single source of contamination that could link all 43 a result, fruits, vegetables, herbs and spices, just to name a few
lots/cases. The cases of HAV could be linked, for example, to
products pertaining to this group category, would deserve the
seven different Polish operators who carry out the freezing
same level of surveillance as do products of animal origin;
and/or to five suppliers of frozen berries in Bulgaria.
- in light of the above, the regime of traceability and/or hygieBecause it was not possible to identify a single source, EFSA
ne requirements for primary production need to be strengtheconcluded that the contamination could still be taking place, ned, whereas Good Hygiene Practice (GHP), Good Manufactunamely at the Polish facilities performing the freezing, or at
ring Practice (GMP) and Good Agricultural Practice (GAP)
the stage of primary production in Poland or Bulgaria. It is also should be also developed and effectively implemented in this
possible that, due to the relatively long shelf-life of the proarea, so as to avoid other undesired food incidents.
ducts, some contaminated lots could still be on the market.
Edition October / 2014
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4
Austrian Regulation
on Allergen Information
Author: Eva Maria Kostenzer | Schönherr, Wien
Certain substances or products which may cause allergies or
intolerances, namely cereals containing gluten, crustaceans,
eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame seeds, sulphur dioxide and sulphites, lupin, molluscs and
products thereof, have to be indicated on prepacked food.
From 13 December 2014 onwards, the name of the allergen
also has to be emphasized in a way that clearly distinguishes it
from the rest of the list of ingredients according to Art. 21
para. 1 lit. b of the new EU-Regulation on food information
1169/2011.
So far, so good. What may be overlooked at first glance is that
in future those allergen rules will also apply to non-prepacked
food as well as food that is packed on the sales premises at
the consumer’s request or prepacked for direct sale (Art. 44
para. 1 lit. a). As a consequence, establishments such as bakeries, restaurants or cafés will have to provide the particulars
about allergens contained in the food they offer to consumers. But how to put this into practice?
Art. 44 para. 2 of Regulation 1169/2011 allows the member
states to adopt national measures concerning the means
through which allergens (or other particulars) are to be made
available for non-prepacked food and, where appropriate, the
form of expression and presentation. As long as member states do not adopt specific national measures concerning nonprepacked food, information on allergens must be provided in
a written form. The Austrian legislator reacted and implemented a regulation on allergen information, which will enter into
force on 13 December 2014.
The main provisions are:
• Food business operators have to transmit information
relating to non-prepacked food that contains allergens
to the final consumer (Sec. 2).
• The allergen information has to be available and easily
accessible and must be provided for the consumer
without request (Sec. 3 para. 1).
• It is sufficient to indicate in a conspicuous place and in
a clear, well legible and, where appropriate, indelible
way that the information can be obtained verbally on
demand (Sec. 3 para. 2).
• The oral information on allergens has to be communicated by persons who were trained for this purpose.
The training needs to be repeated at least every three
years. It must be documented that the training was
carried out. The proof of the first training has to be
provided one year after the entry into force of the
regulation (Sec. 3 para 3).
Edition October / 2014
• Food business operators have to ensure that the information on allergens is based on a written documentation (Sec. 4).
The ministry of health published three guidance documents
about the allergen information in general and the trainings in
particular. According to these guidelines, the food business
operator has to determine the person(s) who will handle
requests regarding allergen information. The person in charge
can also be the food business operator himself.
MMag. Eva Maria Kostenzer, LL.M.,
Associate, Schönherr Rechtsanwälte GmbH
schoenherr.eu/people/eva-maria-kostenzer
Eva Maria Kostenzer has been an associate at Schönherr
since 2012. She specializes in European
and Austrian food law, product law
and litigation. She regularly acts for
Austrian and international clients in
civil and administrative law proceedings. Before joining Schönherr, Eva
Maria gathered experience as university assistant at the Department of European Law and Public International
Law/University of Innsbruck. She graduated with a law degree and a
degree in international economic and business studies
from University of Innsbruck. In 2012 she obtained a
degree in European and International Business and Tax
Law (LL.M., Management Center Innsbruck/Frankfurt
School of Finance and Management).
The food business operator bases the allergen information on
the information received from the supplier. For food for resale
that is not processed by the food business operator, written
documents about the allergens of single products or product
groups have to be issued.
For food produced by the food business operator the allergen
information is based on the ingredients and the recipe. Documentation about the allergenic ingredients has to be available
for each self-manufactured product or product group. With
regard to daily offers or short-term changes in the recipe, the
trained sale and service employees have to be informed
accordingly.
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5
The allergen information can be provided to the consumer in
a written way, e.g. on a label on the foodstuff or on a near
notice board, in the menu or pricelist or in electronic form.
Abbreviations and symbols may be used, as long as their
meaning is explained nearby. If the allergen information is
transmitted verbally, this has to be indicated in the menu or
on a notice board. Finally, the allergen information has to be
kept up to date, especially with regard to changes of the range of food, the composition or the ingredients.
As far as the trainings for verbal allergen information are concerned, their content has to correspond with the scope of
duties of the person(s) in charge. The trainings shall put across
the importance of allergen information, especially what an
allergy or intolerance is and what the effects are. The trained
persons have to become sensitized to the causing of allergic
reactions and have to know the list of allergens in annex II of
Regulation 1169/2011. Furthermore, the persons have to be
informed about how to carry out the allergen information at
work and how to inform the consumer.
The trainings can be carried out by in-house or external
experts who have the relevant expert knowledge about allergens and are capable to impart the training content. Last but
not least, the documentation of the trainings has to be kept
ready and has to be saved for at least three years.
To sum up, the Austrian rules are clearly based on pragmatic
considerations. First of all, it is guaranteed that allergen information is available for consumers. At the same time the rules
allow sufficient leeway with regard to the means of information and the persons in charge. Therefore, the implementation
should be feasible for the concerned food business operators,
including small and medium sized companies.
meyer
Edition October / 2014
Allergeninformationsverordnung, BGBl. II Nr. 175/2014:
http://www.ris.bka.gv.at/Dokumente/BgblAuth/
BGBLA_2014_II_175/BGBLA_2014_II_175.pdf
Leitlinie zur Allergeninformation bei nicht vorverpackten
Lebensmitteln („offene Waren“) im Sinne der
Allergeninformationsverordnung:
https://www.verbrauchergesundheit.gv.at/lebensmittel/
buch/codex/beschluesse/Kennzeichnung_LL,_AIV.
pdf?4guxnd
Leitlinie für die Personalschulung über die Allergeninformation
im Sinne der Allergeninformationsverordnung:
https://www.verbrauchergesundheit.gv.at/lebensmittel/
buch/codex/beschluesse/Kennzeichnung_LL,_AIV_Personalschulung.pdf?4guxnd
Empfehlung zur schriftlichen Allergeninformation bei nicht
vorverpackten Lebensmittel („offene Waren“)
https://www.verbrauchergesundheit.gv.at/lebensmittel/
buch/codex/beschluesse/
Kennzeichnung_Empfehlung_schriftliche_Allergeninformation_Ok.pdf?4kps94
Schönherr
Schönherr is one of the leading legal firms in CEE region
with exciting but also very complex markets that remain
in transition. Their know-how edge in this region, their
optimally positioned company structure, and their distinguished local contacts and networks provide their clients
with a decisive competitive advantage.
on
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Classification of plants and plant parts
in foodstuffs - Official Presentation of the
German “List of Substances”
Autor: Anna Oberloher
Regarding the marketability of botanicals in foodstuffs, the
European legislation is not harmonized, so national regulations can be applied. Many European member states therefore
have compiled their own lists of permitted or prohibited
plants for use in several categories of food in order to provide
optimum protection for consumers and valuable guidance for
operators and competent authorities.
Over the past few years in Germany a list of botanicals has
been compiled. The project was conducted by the “Federal
Office of Consumer Protection and Food Safety” (BVL) and
commissioned by the “Federal Ministry of Food and Agriculture” (BMEL). Recently the so called “List of Substances of the
Competent Federal Government and the Federal State Authorities – Category ‘Plants and plant parts‘” was officially handed
over to the BMEL during a conference at the “Federal Press
Office” in Berlin.
This “List of Substances” is intended to facilitate the legal classification and risk assessment of plants and plant parts for their
use in foodstuffs. A systematic classification of botanicals as
“food”, “medicinal product”, “novel food” or “novel food ingredient” and possible combinations thereof were made using a
decision tree. In addition, the “List of Substances” contains
information on risks arising from the consumption of certain
botanicals. Following Art. 8 of the fortification legislation
(Regulation (EC) No 1925/2006), recommendations for use in
foodstuffs have been made in the form of three partial lists:
List A (substances that are not recommended for the use as
food or food ingredient), List B (substances for which a dose
restriction is required) and List C (substances which could not
be evaluated conclusively due to insufficient data).
The 170-paged report containing about 590 plants and plant
parts is not legally binding. It is open for update in order to
stay abreast of the latest scientific knowledge and market
developments.
The “List of Substances” is available as a PDF file on the website
of the BVL in both German and English.
Edition October / 2014
Anna Oberloher
studies food chemistry at the TU Munich. Scientific final
thesis on botanicals (BelFrIt), supervised by Prof. Meyer.
Internship at meyer.science.
Both, legal and science!
meyer. provide comprehensive advice fulfilling the highest standards of quality to national and international
enterprises in the food industry and the industries for cosmetics, pharmaceuticals and chemicals. Our offices provide tailor-made and sustainable solutions to clients.
meyer. combine sound and traditional legal advice with
an inter-disciplinary approach; close cooperation with
their partner meyer.science GmbH enables them to provide legal and scientific advice from a single source.
meyer´s advisory services also extend to the areas of food
commodity items and other consumer products such as
toys and textiles, focusing on issues of product safety, responsibility and liability as well as risk assessment. In the
area of pharmaceuticals one of the predominant questions is the distinction between pharmaceuticals and other
products such as foods, as well as the law governing
advertising for medicaments.
meyer´s clients profit from the close cooperation between our offices and from a broad network of European
and international experts enabling us to incorporate the
particularities of the relevant markets into our
considerations.
meyer.rechtsanwälte
Partnerschaft mbB
Sophienstrasse 5
D - 80333 Munich
Fon +49 (0)89 8563880-0
www.meyerlegal.de
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7
Myths and Facts about
Innovations in the Food Sector
Author: Joanna Krakowiak | Wardynski and Partners, Warsaw
New technology is most often associated with telecommunications, IT or robotics. Food is seen as a group of products in
which innovation is little important, because it is believed that
consumers are mostly concerned with prices and quality, but
not innovations. However, the dynamic growth in market
share of functional foods calls for a critical review of myths
that have arisen around R&D projects in the food sector.
Myth 1: innovations only for the largest
Stiffening market competition is forcing reductions in production costs and margins. Small and medium entrepreneurs are
succumbing to pressure to lower prices, believing that low
product pricing is their key weapon in the battle for consumers. Often, they mistakenly assume that only multinationals
with dedicated product development centres can afford to
develop products which stand out on the market by meeting
the needs of consumers in new ways. Building a competitive
advantage based solely on product price may lead to a situation where production loses profitability, and the company’s
market position is jeopardised.
Nonetheless, global trends show that the most innovative products originate from small and medium-sized companies: particularly biotech spin-off companies created at universities or
in clusters operating in the vicinities of strong research units.
In addition, the allocation of funds in the Financial Framework
2014-2020, shows that the budget for implementing the
Smart Growth Operational Programme over six years in Poland
is EUR 8.6 billion, which is about PLN 35.9 billion, or an average
of about PLN 6 billion a year. Although the detailed allocation
of funds under this programme will probably only be known
at the end of this year, but considering the smart specialisations adopted by Poland, which include innovative technologies, processes and products for the agri-food sector, we may
expect that the a significant portion of these funds will go to
companies in the food sector. These will be companies which
present ambitious and well-prepared feasibility plans for
implementing new technologies for producing, packaging or
preserving foods. They will have a chance to gain financial
leverage, which will enable them to introduce innovative products on the market, thereby gaining a competitive
advantage.
Edition October / 2014
Myth 2: R&D only within the firm
The economic downturn means that few companies have
their own development departments which can research new
products. In extreme cases, funds are invested mainly in marketing and promotion, and new products are developed only
by marketing specialists, rather than food technologists. This
strategy generates revenues in the short term, but in the long
term it can marginalise the market position of the company,
which due to insufficient investment in developing innovative
products will be just one of many followers and never a leader
in the segment or market niche.
Joanna Krakowiak
Wardyński & Partners
Joanna Krakowiak is a legal adviser and a member of the
Life Science and Regulatory Law Practice. She is also responsible for the biomedical and modern foods and
research and development (R&D) areas in the New Technologies Practice.
She specialises in advising companies
from food and pharma sector in product classification, labelling as well as
marketing & promotion issues and
represents them in proceedings before
the regulatory authorities and administrative courts.
She is as a Vice-President of the Working Group on International Biotechnology at the Union Internationale des Avocats. She chairs
the Ethics Committee of the Polish Council for Supplements and Nutritional Foods (KRSiO) and serves as an
expert for the association
Joanna Krakowiak
Wardyński & Partners
Al. Ujazdowskie 10, 00-478 Warszawa, Poland
E-mail: [email protected]
Tel.: (+48) 22 437 82 00, 22 537 82 00
www.wardynski.com.pl
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8
Globally, as well as in Poland, a market is beginning to operate
for scientific research which allows outsourcing of new product development processes to specialist research institutions.
This allows the outsourcing of those types of research and
development, which cannot be carried out within a firm due
to the high costs of maintaining such teams in-house. Establishing cooperation with universities and research institutes
specialising in implementation research on such areas as
developing novel compositions of food supplements, and
using biological ingredients or nanomaterials in functional
foods may be a solution that will help businesses access the
latest technologies and facilitate the implementation of those
technologies in their products.
The are various legal forms available for cooperation between
enterprises and scientific research institutes, from contracts for
specific projects, to continuous cooperation agreements and
for creating multi-centre Knowledge and Innovation Communities (centres for excellence). Consortium agreements between companies in the food sector and research institutes
may be of particularly popularity, because the conclusion of
such agreements is a requirement for obtaining EU funding
under the Smart Growth Programme.
Regardless of the particular model of cooperation, it is essential to precisely define the purpose to be served by the contract, the obligations between parties - particularly as to financial commitments, the delimitation of tasks carried out within
the framework of the agreement from scientists’ other obligations, the allocation of intellectual property rights that may arise in the course of projects, and the protection of provided
business secrets.
Wardyński & Partners
Wardyński & Partners is an independent Polish law firm
serving businesses, financial institutions, and public and
private organisations, from Poland and abroad.
Polish clients value our expertise and skill at solving their
most difficult legal problems. Foreign clients also appreciate our familiarity with Poland’s legal, economic and cultural realities, combined with the experience the firm has
developed over our many years of serving international
companies.
Wardyński draw upon leading global best practice in law
firm management and high-tech solutions. Wardyński
continually strive to improve the firm’s operations, which
redounds to the benefit of our clients.
The firm now has over 100 lawyers,
serving clients in Polish, English,
French, German, Spanish, Russian,
Czech and Korean. Offices in Warsaw, Poznań, Wrocław, Kraków and
Brussels.
Myth 3 – Regulatory provisions are a barrier for introducing innovations onto the market
To ensure that the path of introducing a new product to the
market ends in success, it is necessary at an early stage of
work on it to take into account the regulatory conditions for
introducing a product onto the market, particularly in the area
of product classification and the obligations that arise from
the given classification. For example, if a product does not
have a chance to enter the market as a food supplement, it
may be worth developing it for specific nutritional needs of
people with metabolic disorders and to market it as a foods
for special medical purposes (FSMP).
Representatives of both business and science raise that provisions of food law, which require products to be classified
under specific legal categories, create lists of permitted ingredients or health and nutritional claims that a producer may
communicate to consumers, but only when specific conditions are met, create a significant barrier in bringing innovative
food products to the market.
It should also be noted that the obligations under food law
are primarily intended to ensure product safety and the protection of consumers. They should therefore be interpreted in
a way which is appropriate to the purposes they serve, and
not in a way that may result in excessive burdens on manufacturers, particularly when such interpretation is not associated
with any real benefit to consumers.
An example is that the legal risk associated with the unregulated status of plant origin food ingredients, combined with
regulations on communicating health claims restricting the
possibility of informing consumers on the impact of food containing such ingredients on health, often means that innovative products have no chance of entering the market.
[This article has been published firstly by the British Polish
Chamber of Commerce in its magazine titled “Contact online”
issue no. 14 (109) 2014]
More articles from
Edition October / 2014
meyer
on
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9
Recent decisions of the German
Federal High Court of Justice
relating to Reg. (EC) No 1924/2006
Author: Anna Märtlbauer
“Praebiotik“ (Milupa vs. Hipp)
BGH, Urteil vom 26. Februar 2014 - I ZR 178/12
The lawsuit Milupa vs. Hipp concerned the question whether
the claims “Praebiotik® + Probiotik®”, “with natural lactic acid
populations” and “Praebiotik® to support a healthy intestinal
flora” made on baby food were health claims in terms of Art.
2 para. 2 no. 5 Reg. (EC) No. 1924/2006. The German Federal
High Court of Justice (BGH) answered in the affirmative, stating that a health claim was on hand, if according to an average consumer’s comprehension, which is affected by certain
expectations and knowledge, a connection between a food
component and the consumer’s state of health is suggested.
The BGH then stated that the transitional measures regulated
in Art. 28 para 6 lit. b Reg. No (EC) 1924/2006 were not applicable on the claims in question as a strict standard had to
applied by examining whether a certain health claim corresponded with an applied claim in terms of Art. 28 para 6 lit. b
Reg. (EC) No. 1924/2006. The differences in content between
a label referring to a company (here: “Praebiotik®”) and the
purely descriptive claim of a certain ingredient (here: “Prebiotic fibre supports development of healthy intestinal flora”)
were too fundamental to apply the transitional provision
regulated in Art. 28 para 6 lit. b Reg. (EC) No. 1924/2006.
Commission Regulation (EU) No 116/2010 of 9 February 2010
must be interpreted as meaning that the obligations to provide information laid down in Article 10(2) of that regulation
were already in force in 2010 as regards health claims that
were not prohibited on the basis of Article 10(1), read in conjunction with Article 28(5) and (6) of that regulation.
Anna Märtlbauer
studies law at the “Ludwig-Maximilian-Universität” of
Munich, main focus 3: Competition law, intellectual
property and media law. Research associate at meyer.
rechtsanwälte.
Although the request for a preliminary ruling only concerned
the temporal application of the obligations to provide information laid down in Article 10(2) of Regulation No 1924/2006, the
main question in the lawsuit between Ehrmann and the Wettbewerbszentrale is whether the advertising slogan in question
“as important as a glass of milk” is a health claim at all. During
„Original Bach-Blüten“
the hearing two judges of the ECJ mentioned two other claims
- “pleasure is good for you” and “as good as a daily spoon of oliBGH I ZR 221/12, 24.7.2014
ve oil” - as examples for health claims outside the scope of the
The claim “Original Bach Flowers“ made on food supplements
Regulation (EC) No. 1924/2006. A considerably difference betwas not regarded as a health claim in terms of Art. 2 para 5 Reg. ween the claim in question and especially the second of these
(EC) No 1924/2006 by the BGH as the claim “Original Bach Flow- claims cannot be seen. However, even if the claim is health
ers” on its own was neutral in relation to health. But the line bet- claim in terms of Art. 2 (5) Reg. (EC) 1924/2006 it is a non-speciween such neutral claims and health claims is rather thin when fic one in terms of Art. 10 (3) Reg. (EC) No. 1924/2006. Refeit comes to “Bach Flower” products as consumers, who know the rence to general, non-specific benefits of the nutrient or food
“Bach Flower” products also know about their (supposed) effect for overall good health or health-related well-being are allowed
of “recovering the mental balance”, which clearly is a health
if accompanied by a specific health claim included in the lists
claim in terms of Art. 13 para 1 Reg. (EC) No. 1924/2006. For this provided for in Article 13 or 14. According to the BGH non-spereason courts for example prohibited claims such as “RESCUE® - cific health claims are claims whose statements refer to the
The Original Bach® Flower blend”, “gladly used in emotional exci- wellbeing supposed to be supported or increased by consuting situations, e.g. at work” or “Rescue Night Spray”.
ming the product in question, e.g. “supporting an optimal performance” or “increases endurance and performance”. Specific
Ehrmann vs. Wettbewerbszentrale – „Monsterbacke“
claims on the other hand are claims expressing or suggesting
certain “body functions to be supported” by consuming the
EuGH – C-609/12 – Urteil v. 10.04.2014
product. This said, the Ehrmann slogan has to be classified as
Regulation (EC) No 1924/2006 of 20 December 2006 on nutri- non-specific as there are no specific body functions, which the
tion and health claims made on foods, as amended by
product could probably support, mentioned.
Edition October / 2014
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10
New Law –
in headwords & details
Below new European regulations and directives from May 2014 to date. The table shows the matching No., under which the
legal norm can be found in the (German) Textbook C.H.Beck, Meyer Lebensmittelrecht, the particular legal norm (2nd column)
and in the 3rd column the current amendment. Via hyperlink the new legal norms can be recalled online.
Meyer Textbook C.H.Beck
Nr.
Legal Norm
Amendment
Labelling
0220
Commission Implementing Regulation (EU)
No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of
gluten in food Text with EEA relevance (OJ L
228, 31.07.2014, p. 5–8)
Quality Schemes for Agricultural Products and Foodstuffs
405
Commission Delegated Regulation (EU) No
664/2014 of 18 December 2013 supplementing
Regulation (EU) No 1151/2012 of the European
Parliament and of the Council with regard to
the establishment of the Union symbols for
protected designations of origin, protected
geographical indications and traditional specialities guaranteed and with regard to certain
rules on sourcing, certain procedural rules and
certain additional transitional rules (OJ L 179,
19/06/2014, p. 17–22)
410
Commission Delegated Regulation (EU) No
665/2014 of 11 March 2014 supplementing
Regulation (EU) No 1151/2012 of the European
Parliament and of the Council with regard to
conditions of use of the optional quality term
‘mountain product’ (OJ L 179, 19/06/2014, p.
23–25)
415
Commission Implementing Regulation (EU)
No 668/2014 of 13 June 2014 laying down
rules for the application of Regulation (EU) No
1151/2012 of the European Parliament and of
the Council on quality schemes for agricultural
products and foodstuffs (OJ L 179, 19/06/2014,
p. 36–61)
Edition October / 2014
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11
Meyer Textbook C.H.Beck
Nr.
Legal Norm
Amendment
Food Additives, Enzymes
600
Regulation (EC) No 1333/2008 of the European
Parliament and of the Council of 16 December
2008 on food additives (OJ L 354, 31.12.2008)
- Commission Regulation (EU) No 923/2014 of 25 August
2014 amending Annex II to Regulation (EC) No 1333/2008 of
the European Parliament and of the Council as regards the
use of aluminium lakes of riboflavins (E 101) and cochineal,
carminic acid, carmines (E 120) in certain food categories and
Annex to Regulation (EU) No 231/2012 as regards the specifications for riboflavins (E 101) (OJ L 252, 26.08.2014, p. 11–17)
- Commission Regulation (EU) No 957/2014 of 10 September 2014 amending Annex II to Regulation (EC) No
1333/2008 of the European Parliament and of the Council
and the Annex to Commission Regulation (EU) No 231/2012
as regards the removal of montan acid esters (E 912)
(OJ L 270, 11.09.2014, p. 1–3)
- Commission Regulation (EU) No 969/2014 of 12 September 2014 amending Annex II to Regulation (EC) No
1333/2008 of the European Parliament and of the Council as
regards the use of Calcium ascorbate (E 302) and Sodium
alginate (E 401) in certain unprocessed fruit and vegetables
(OJ L 272, 13.09.2014, p. 8–10)
620
Commission Regulation (EU) No 231/2012 of 9
March 2012 laying down specifications for food
additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (L 83/1, 22.3.2012)
- Commission Regulation (EU) No 923/2014 of 25 August
2014 amending Annex II to Regulation (EC) No 1333/2008 of
the European Parliament and of the Council as regards the
use of aluminium lakes of riboflavins (E 101) and cochineal,
carminic acid, carmines (E 120) in certain food categories and
Annex to Regulation (EU) No 231/2012 as regards the specifications for riboflavins (E 101) (OJ L 252, 26.08.2014, p. 11–17)
- Commission Regulation (EU) No 957/2014 of 10 September 2014 amending Annex II to Regulation (EC) No
1333/2008 of the European Parliament and of the Council
and the Annex to Commission Regulation (EU) No 231/2012
as regards the removal of montan acid esters (E 912)
(OJ L 270, 11.09.2014, p. 1–3)
- Commission Regulation (EU) No 966/2014 of 12 September 2014 amending Annex to Regulation (EU) No 231/2012
laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European
Parliament and of the Council as regards specifications for
calcium propionate (OJ L 272, 13.09.2014, p. 1–2)
Contaminants, Residues
1220
Regulation (EC) No 396/2005 of the European
Parliament and of the Council of 23 February
2005 on maximum residue levels of pesticides
in or on food and feed of plant and animal origin and amending Council Directive 91/414/
EEC (Official Journal L 70/1, 16.3.2005)
Edition October / 2014
- Commission Regulation (EU) No 703/2014 of 19 June 2014
amending Annexes II, III and V to Regulation (EC) No
396/2005 of the European Parliament and of the Council as
regards maximum residue levels for acibenzolar-S-methyl,
ethoxyquin, flusilazole, isoxaflutole, molinate, propoxycarbazone, pyraflufen-ethyl, quinoclamine and warfarin in or on
certain products (OJ L 186, 26.6.2014, p. 1–48)
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12
Meyer Textbook C.H.Beck
Nr.
Legal Norm
Amendment
1220
Regulation (EC) No 396/2005 of the European
Parliament and of the Council of 23 February
2005 on maximum residue levels of pesticides
in or on food and feed of plant and animal origin and amending Council Directive 91/414/
EEC (Official Journal L 70/1, 16.3.2005)
- Commission Regulation (EU) No 737/2014 of 24 June 2014
amending Annexes II and III to Regulation (EC) No 396/2005
of the European Parliament and of the Council as regards
maximum residue levels for 2-phenylphenol, chlormequat,
cyflufenamid, cyfluthrin, dicamba, fluopicolide, flutriafol, fosetyl, indoxacarb, isoprothiolane, mandipropamid, metaldehyde, metconazole, phosmet, picloram, propyzamide, pyriproxyfen, saflufenacil, spinosad and trifloxystrobin in or on certain
products (OJ L 202, 10.07.2014, p. 1–63)
- Commission Regulation (EU) No 752/2014 of 24 June 2014
replacing Annex I to Regulation (EC) No 396/2005 of the
European Parliament and of the Council
(OJ L 208, 15.07.2014, p. 1–71)
- Commission Regulation (EU) No 991/2014 of 19 September 2014 amending Annex III to Regulation (EC) No 396/2005
of the European Parliament and of the Council as regards
maximum residue levels for fosetyl in or on certain products
(OJ L 279, 23.09.2014, p. 1–16)
Organic Products
2620
Commission Regulation (EC) No 1235/2008 of 8
December 2008 laying down detailed rules for
implementation of Council Regulation (EC) No
834/2007 as regards the arrangements for
imports of organic products from third countries (Official Journal L 334/25, 12.12.2008)
- Commission Implementing Regulation (EU) No 829/2014
of 30 July 2014 amending and correcting Regulation (EC) No
1235/2008 laying down detailed rules for implementation of
Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries
(OJ L 228, 31.07.2014, p. 9–15)
2640
Commission Regulation (EC) No 889/2008 of 5
September 2008 laying down detailed rules for
the implementation of Council Regulation (EC)
No 834/2007 on organic production and labelling of organic products with regard to organic
production, labelling and control (OJ L 250,
18.9.2008, p.1)
- Commission Implementing Regulation (EU) No 836/2014
of 31 July 2014 amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council
Regulation (EC) No 834/2007 on organic production and
labelling of organic products with regard to organic production, labelling and control (OJ L 230, 01.08.2014, p. 10–11)
Beef
3700
Regulation (EC) No 1760/2000 as regards elect- - REGULATION (EU) No 653/2014 OF THE EUROPEAN PARLIAronic identification of bovine animals and label- MENT AND OF THE COUNCIL of 15 May 2014 amending
ling of beef
Regulation (EC) No 1760/2000 as regards electronic identification of bovine animals and labelling of beef (Official Journal of the European Union L 189/33, 27.6.2014)
Food Monitoring
8515
Commission Regulation (EC) No 152/2009 of 27
January 2009 laying down the methods of sampling and analysis for the official control of feed
(OJ L 54, 26.2.2009, p. 1)
Edition October / 2014
- Commission Regulation (EU) No 709/2014 of 20 June 2014
amending Regulation (EC) No 152/2009 as regards the determination of the levels of dioxins and polychlorinated biphenyls (OJ L 188, 27.6.2014, p. 1–18)
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Meyer Textbook C.H.Beck
Nr.
Legal Norm
Amendment
Fruit, Vegetables, Grain and Spices
5200
Commission Implementing Regulation (EU) No
543/2011 of 7 June 2011 laying down detailed
rules for the application of Council Regulation
(EC) No 1234/2007 in respect of the fruit and
vegetables and processed fruit and vegetables
sectors (Official Journal, 15.6.2011, L 157/1)
- Commission Implementing Regulation (EU) No 443/2014
of 30 April 2014 amending Implementing Regulation (EU) No
543/2011 as regards the trigger levels for additional duties on
tomatoes, cucumbers, table grapes, apricots, cherries, other
than sour, peaches, including nectarines, and plums
(Official Journal L 130, 01/05/2014, p. 41–42)
8540
Commission Implementing Regulation (EU) No
543/2011 of 7 June 2011 laying down detailed
rules for the application of Council Regulation
(EC) No 1234/2007 in respect of the fruit and
vegetables and processed fruit and vegetables
sectors (Official Journal, 15.6.2011, L 157/1)
- Commission Implementing Regulation (EU) No 718/2014
of 27 June 2014 amending Regulation (EC) No 669/2009
implementing Regulation (EC) No 882/2004 of the European
Parliament and of the Council as regards the increased level
of official controls on imports of certain feed and food of
non-animal origin (OJ L 190, 28.6.2014, p. 55–62)
- Commission Implementing Regulation (EU) No 1021/2014
of 26 September 2014 amending Annex I to Regulation (EC)
No 669/2009 implementing Regulation (EC) No 882/2004 of
the European Parliament and of the Council as regards the
increased level of official controls on imports of certain feed
and food of non-animal origin (OJ L 283, 27.09.2014, p. 32–39)
Product Safety
9020
Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys
- Commission Directive 2014/84/EU of 30 June 2014 amending Appendix A of Annex II to Directive 2009/48/EC of the
European Parliament and of the Council on the safety of toys,
as regards nickel (OJ L 192, 01.07.2014, p. 49–51)
Prof. Dr. Alfred Hagen Meyer
Professor Dr. Meyer is a partner of meyer.rechtsanwälte partnerschaft mbB.
The focus of his legal work lies on all facets of food law and the law on food contact materials and commodity items, e.g. product development, labelling and health claims, risk assessment and crisis management as well as lobbying at the national and European levels.
An honorary professor at the TU Munich, Prof. Meyer has lectured on food law at the Institute for Food
Chemistry, TU Munich, since the 1995/1996.
Prof. Dr. Meyer‘s academic achievements are evidenced by over 200 publications.
Prof. Dr. Meyer is chairman of the committee on legal affairs of the German Association on Food for Specific Groups (Diätverband), managing director of the society for the Research Centre for German and European Food Law in Bayreuth and
chairman of the administrative board of the German Nutrition Society (DGE).
Edition October / 2014
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14
Regulatory News
Authors: Uta Verbeek, Kerstin Frohnwieser & Brigitte Ruisinger | meyer.science GmbH plus Veronika Winkler | meyer.rechtsanwälte mbH
CONTENT
1. EFSA
15
Public consultation on the draft Guidance Document
on the agronomic and phenotypic characterisation of
genetically modified plants
15
Electronic submissions introduced for regulated product
applications15
Food enzyme opinions published in full
16
Food enzymes: suitability checklist helps applicants
submit correct data
16
EFSA updates advice on infant and follow-on formulae
16
EFSA published Scientific Opinion on Dietary Reference
Values for Niacin
16
2. BfR
Health assessment of soft drinks with added brominated
vegetable oils
16
16
1. EFSA
Public consultation on the draft Guidance Document
on the agronomic and phenotypic characterisation of
genetically modified plants
The European Food Safety Authority’s Panel on Genetically
Modified Organisms (EFSA GMO Panel) has launched an open
consultation on a draft Guidance Document on the agronomic and phenotypic characterisation of genetically modified
plants.
The aim of this draft Document is to provide guidance for the
agronomic and phenotypic characterisation of GM plants, and
will assist applicants in the generation, analysis and interpretation of the agronomic/phenotypic dataset submitted as part
of their GM plant applications in the frame of Regulation (EC)
No 1829/2003
This draft Document provides guidelines supplementing the
general recommendation published in the EFSA GMO Panel
guidelines on the risk assessment of food and feed from GM
plants, the environmental risk assessment of GM plants (EFSA,
2010) and the Implementing Regulation (EU) No 503/2013.
Interested parties are invited to submit written comments by
6 November 2014. Read more...
Edition October / 2014
Polyethylene-containing microplastic particles:
health risk resulting from the use of skin cleansing and
dental care products is unlikely
Prize-winning BfR app for poisoning accidents among children
Assessment of pain and suffering in test animals
EFSA and German BfR decide consumption of chlorinated
chicken is safe
EHEC, salmonella etc: new method helps to identify
the causes of disease outbreaks
3. Others
CVUA Stuttgart
New investigations: Coffee pad machines contain
no lead and nickel
Phtalate compounds in wine
Study concerning the distinction between colouring foodstuffs
and food colours 16
17
17
17
17
17
17
18
18
Electronic submissions introduced for regulated product applications
Applications for regulated products such as feed additives,
food enzymes and health claims should now be submitted to
the European Food Safety Authority (EFSA) by electronic
means. The initiative, which requires applicants to use electronic mediums such as CD ROMs or USB keys to submit technical dossiers, will cut bureaucracy and streamline the risk
assessment process, said EFSA.
All applications submitted to EFSA, either by an applicant,
Member State or the European Commission, should include
the original of a signed cover letter listing annexes, their tables
of content and the mandate. Read more...
Food enzyme opinions published in full
EFSA has published the full text of its first food enzyme evaluations in the context of the Regulation EC 1331/2008 following an agreement on business information between the
European Commission and the enzyme producer. Summaries
of the first batch of food enzyme opinions were published
earlier this year and heralded the start of a new chapter in
EFSA’s work. EFSA’s Panel on Food Contact Materials, Enzymes,
© Copyright
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15
Flavourings and Processing Aids will carry out safety assessments on around 300 food enzyme applications in the
coming years. Read more... http://www.efsa.europa.eu/en/
topics/topic/foodenzymes.htm
pregnant and lactating women, the Panel considers that there
is no evidence that the relationship between niacin requirement and energy requirement differs from that of adults;
therefore, the AR and PRI for adults are also applied to these
age and life stage groups. Read more...
Food enzymes: suitability checklist helps applicants
submit correct data
New guidance from EFSA includes a checklist of all the information that must be submitted as part of an application to
put a food enzyme on the market in the European Union (EU).
The suitability checklist is designed to be used by applicants
to ensure EFSA receives all the necessary administrative and
scientific data to carry out its assessment of a food enzyme
application. In addition, the document sets out when and
how applicants can contact EFSA staff during the evaluation
process. Read more...
2. BfR
Health assessment of soft drinks with added brominated vegetable oils
Brominated vegetable oils can be used as stabilisers for aroma
oils in fruity flavoured beverages. In the USA these substances
are approved for up to 15 mg/L (15 ppm). In the European
Union (EU), these vegetable oils are not permitted as additives.
For this reason, products containing brominated vegetable
Checklist: http://www.efsa.europa.eu/de/supporting/
oils and / or their components (brominated fatty acids) candoc/638eax1.xls
not, irrespective of the content, be traded. At the instance of
the German food safety authority which rejected two beverages imported from the USA, the BfR was asked to assess the
EFSA updates advice on infant and follow-on formulae health effects of soft drinks to which brominated vegetable
oils are added.
EFSA has recommended intake levels of energy, macronutrients and micronutrients in infant and follow-on formulae. The Based on the current state of
recommendations are included in a Scientific Opinion on the knowledge, no acute risks
essential composition of infant and follow-on formulae, which from soft drinks with conreviews advice provided by the Scientific Committee on Food tents up to 15 mg/L of broin 2003 taking into account more recent evidence. It follows
minated fatty acids can be
an EFSA Opinion published in 2013 on nutrient requirements derived. In the opinion of the
and dietary intakes of infants and young children in the Euro- BfR, it is notably not sufficipean Union.
ently clear whether brominated fatty acids may have any longterm health effects. The same applies to their ac-cumulation
potential in humans which may be higher than in the tested
animal species. In this context, the high accumulation levels
EFSA published Scientific Opinion on Dietary Refeobserved in children in particular requires clarification. As a
rence Values for Niacin
general principle, the use of substances which have high
accumulation potential in humans is to be seen as undesirable
EFSA derived Dietary Reference Values (DRVs) for niacin. Niacin in food production. Read more...
is a generic term for nicotinic acid and nicotinamide. Niacin
can also be synthesised in the human body from the indispensable amino acid tryptophan. In the absence of new scien- Polyethylene-containing microplastic particles: health
tific data, the Panel endorses the Average Requirement (AR)
risk resulting from the use of skin cleansing and dental
for adults of 1.3 mg
care products is unlikely
niacin equivalent (NE)/
MJ (5.5 mg NE/1 000
Some cosmetic products such as peelings, shower gels and
kcal) adopted by the
toothpastes are promoted as having an especially gentle
Scientific Committee
cleansing effect on the skin or teeth. For this purpose, such
for Food (1993), based products may contain microplastic particles which usually
on data on urinary
consist of polyethylene (PE) and are between 0.1 and 1 milliexcretion of niacin
metre (mm) in size.
metabolites as an endpoint. The Population Reference Intake
(PRI) of 1.6 mg NE/MJ (6.6 mg NE/1.000 kcal) is derived from
The Federal Institute for Risk Assessment (BfR) has researched
the AR assuming a coefficient of variation of 10 %. For infants the question whether dermal absorption or unintentional oral
aged 7-11 months, children and adolescents, as well as for
ingestion of PE microplastic particles from cosmetic products
Edition October / 2014
© Copyright
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16
pose a health risk. Based on the current state of knowledge,
the BfR concludes that the use of cosmetic products containing PE microplastic particles does not pose a health risk to
consumers. Read more...
Prize-winning BfR app for poisoning accidents among
children
Doctors, pharmacies and caregivers are called upon to draw
attention to the BfR app “Poisoning accidents among children”
of the Federal Institute for Risk Assessment (BfR) by means of
free posters. Among other things, the application tells parents
and minders about the clinical picture of different products
and what first-aid measures are required. In the event of an
emergency, a direct connection to the German Poison Information Centre can be established. For doctors, pharmacies
and minders, free posters and memo cards on the app are
available. Read more…
Assessment of pain and suffering in test animals
New rules in the European Union (EU) for the protection of
laboratory animals require assessment of pain that these animals may experience during scientific experiments. The Federal Institute for Risk Assessment (BfR) published an article in
the science magazine “Nature” about the national regulations
on stress classification (Nature. 2014 Aug 07;512(7512):28).
The basis for the national regulation was an expert workshop
to develop guidance on how to assess the severity of the
maintenance of genetically altered animals which took place
in 2013.
EFSA and German BfR decide consumption of chlorinated chicken is safe
Originating from the negotiation about a free trade agreement between the European Union and the United States
(“TTIP”), a heated debate is currently taking place in Germany
whether or not chlorinated chicken, so called “Chlorhühnchen”, should be served at German dinner tables in the future.
In order to reduce the pathogens, it is common practice in the
USA to dive the poultry into a chlorine solution, which
numerous consumers round here consider outrageous. The
“European Food Safety Authority” (EFSA) already published
opinions concerning the “treatment of poultry carcasses with
chlorine dioxide, acidified sodium chlorite […]”. Now an
expert of the “German Federal Institute for Risk Assessment”
(BfR ) takes a stand. Read more ...
EHEC, salmonella etc: new method helps to identify
the causes of disease outbreaks
“In the event of a disease outbreak caused by pathogens such
as EHEC, campylobacter or salmonella in food, the
Edition October / 2014
Uta Verbeek
Uta Verbeek, Ph.D., is the managing
director of meyer.science GmbH. She is
a pharmacist and holds a Ph.D. in pharmacology and toxicology. Mrs. Verbeek
gained her knowledge and experiences from working in various sectors of
the pharmaceutical industry, amongst
others regulatory, medical and clinical
affairs. Since 2010 she works as consultant for food, cosmetic and pharmaceutical companies. The focus of her consulting work
lies on borderline issues, health claims, dietetic foods,
novel foods, food contact materials and risk assessment.
contaminated foods must be identified as quickly as possible
in order to keep the number of affected persons down”, says
Professor Dr. Dr. Andreas Hensel, President of the Federal Institute for Risk Assessment (BfR). In cooperation with the IBM
Almaden Research Center and Johns Hopkins Bloomberg
School of Public Health, the BfR has developed a probabilitybased method which can help to identify the cause of disease
outbreaks more rapidly. Read more…
3. Others
CVUA Stuttgart
New investigations: Coffee pad machines contain
no lead and nickel
In the year 2007 the CVUA Stuttgart tested 17 fully-automated
coffee/espresso machines whereby seven machines released
nickel in amounts of over 0.1 mg/l and three machines
released lead in the coffee and/or in the heated steam at the
first usage and after deliming.
In another test series in the year 2011 no lead or nickel was
found. This year in February 2014 the CVUA Stuttgart again
tested nine fully automated coffee machines. This time the
coffee from the tested machines contained neither lead nor
nickel, elements like chrome, copper, manganese and zinc
were also inconspicuous.
In 2013 stricter guidelines for metals and alloys that are used
in food contact materials were published by the Council of
Europe: 0.01 mg/kg for lead and 0.14 mg/kg (temporarily 0.7
mg/kg) for nickel. Those guidelines are not legally binding, but
rather a measure for maintaining good manufacturing practice and technical quality.
Earlier this year the German Federal Institute for Risk
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the European Union now published a resolution “concerning
the adoption of the work programme and the financing for
the year 2014 of activities in the food and feed area to ensure
the application of the food and feed legislation” which involves under Annex 4.4 the announcement to carry out a study
Phtalate compounds in wine
concerning the distinction between colouring foodstuffs and
food colours, in cooperation with Joint Research Centre (JRC).
Phtalates are chemical compounds used in the industry as sof- The goal is to establish the previously named reference values
tening agents in plastics. They have major potential as hormo- for the source materials “in order to implement the Guidance
ne disruptors, but their toxicity varies according to the type of on the classification of food extracts with colouring properties”
phtalate: some for example have a toxic effect on the immune estimating a budget of 75.230 €.
system, others on the liver. Therefore different limits exist for
each phtalate and their use is regulated on international level.
They are for example prohibited in toys, cosmetics, childcare
products and food packaging.
Assessment (BfR) discovered that espresso machines containing filters have a greater degree of lead solubility, especially
after being delimed. Read more ...
Now a study published in “Food Additives and Contaminants” analysing phthalate concentrations in a variety of
French wines and spirits reveals that “59% of the wines contained significant quantities of DBP”, a particular form of phthalate. It seems that the “epoxy resin coatings used on vats represented the major source of contamination”. Read more ...
Study concerning the distinction between colouring
foodstuffs and food colours
On 16th December 2008 the European Union published the
“Regulation (EC) No 1333/2008 on food additives” (Official
Journal L 354/16, 16.12.2008). Regarding coloured foodstuff a
distinction between colours on the one hand and colouring
food on the other has been made. Colours are added to foodstuff serving a certain purpose as to “restore the original
appearance”, to “make food visually more appealing” or to “give
colour to food otherwise colou rless”. They are normally not
consumed as foodstuffs but obtained through chemical and/
or physical processes called selective extraction (from foodstuff ). These “extracts” are considered as food additives and
therefore requiring licensing. Colouring foods however are
“incorporated during the manufacturing” due to “aromatic,
sapid or nutritive properties together with [only] a secondary
colouring effect”. Regarded as natural foodstuff, no authorization is compulsory. Following the “Guidance notes on the classification of food extracts with colouring properties” from
29th November 2011, “the ratio of the content of pigments to
that of the nutritive or aromatic constituents in the primary
extract […] [are compared to] that present in the source
material” in order to differentiate. Reference Values for the
source materials which shall be found in Annex III haven’t
been elaborated yet. In the Official Journal of 3rd June 2014
Edition October / 2014
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Authors of this issue
Kerstin Frohnwieser
Regulatory News
Eva Maria Kostenzer
‘Austrian Regulation on Allergen Information’
Joanna Krakowiak
‘Myths and Facts about Innovations in the Food Sector’
Anna Märtlbauer
German Supreme Court on health claims
Prof. Dr. Alfred H. Meyer
New law
Dr. Brigitte Ruisinger
Regulatory News
Cesare Varallo
‘Hepatitis A in frozen berries‘
Dr. Uta Verbeek
Regulatory News
Veronika Winkler
Regulatory News
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