food news - meyer.rechtsanwälte

Transcription

food news
Edition October / 2015
legal and regulatory news
CONTENT
Food innovation – too much debate, too few facts?
by M. Friberg
1
Compliance in the food industry? Minimising liability by
regulating conduct. A critical evaluation,
by A. H. Meyer / A. Märtlbauer 3
CJEU Ruling On Health Claims, by A.-M. Taylor7
Composition in focus in the UK as the health agenda
is a central focus, by D. Watkins / A.-M. Taylor10
In brief, by D. Watkins11
TURKEY – recent developments in relation to the use
of genetically modified organisms, by K. Üçer / C. Çırnaz 12
Recent decisions of the Austrian
regional administrative courts relating to food law matters,
by E. M. Kostenzer14
Update on Food Law in China: New Food Safety Law 2015,
by J.-M. Scheil 16
Regulatory News, by meyer.science18
New Law – in headwords & details, by A.H. Meyer24
Imprint
31
Food innovation – too much debate,
too few facts?
Author: Magnus Friberg | Gulliksson
In the past year we have seen both a decision allowing EU
Member States to prohibit genetically modified crops and the
blocking of a Commission proposal that would enable Member States to stop genetically modified food products from
entering the market. Food innovation – especially of GM and
nanotech ingredients – is also inhibited by disclosure requirements in food information legislation. The consumer
community’s reluctance to accept innovative foods that may
sound a bit suspicious makes commercialization difficult. New
foods with enhanced health properties have difficulty
reaching consumers. These factors lead innovators to turn
their attention to other industries. Many probiotic companies
in Sweden are thankful for the U.S. and other markets when
the EU won’t deliver.
food innovators turn their attention
to other industries
These are, to a large extent, debate- rather than fact-driven
problems.
There are a number of ways to look at this issue. One is of
course that the consumer should have the right to be properly informed as to what they are about to put in their mouths,
including truthful information about the products’ possible
effects or other properties. On the other hand, the situation
prompts the question: are not legislative measures primarily
driven by politics and NGO’s – not necessarily in that order?
Second, have we taken this to a level where legislation hinders
scientific progress that might be necessary to saving the environment, feeding the planet and improving public health? Is
our resistance justified, or is it a symptom of a luxury problem?
The Commission’s proposal that would have enabled Member
States to prevent products from entering the market on
account of genetically modified ingredients might seem positive to the average consumer. Every parent hopes their children will not be exposed to E-numbers, pesticide residues, and
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Magnus Friberg
Magnus Friberg is advocate and partner at Gulliksson Advocates, Sweden.
Gulliksson Advocates is a full services
business law firm with its base in intellectual property and the life sciences.
Gulliksson
Gulliksson is the law firm that stands out from the crowd.
We are a commercial law firm specialized in intellectual
property law, company law, mergers & acquisitions, contracts and litigation. At Gulliksson you will find both advocates, business lawyers and authorized Intellectual Property attorneys. Our unique service mix makes us one of the
largest law firms in Sweden with
regard to intellectual property and a
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opportunities.
Consumers and the political community are both divided over
these issues. If you ask a consumer in Sweden, he or she
would probably say yes to innovations that can improve
health, feed the world, and help the environment, yet no to
GMO and possibly also nanotech ingredients. This sort of skepticism is fed by a lack of understanding and our tendency to
give credence to doomsday prophecies. Perhaps the situation
is even worse for conventional foods, as consumers seem to
get their dietary advice from tabloids - the same place they
get stock and gambling tips. Politicians are, to a large extent,
ideologically predetermined or driven by the electorate, neither of which indicates that they will share unbiased scientific
information with the public.
For the food industry, it is a question of building credibility.
Good, safe, unadulterated products, and transparency with
regard to content and production methods. But is that
enough? You also need consumers acting with reason rather
than superstition or in reaction to the latest headlines. This is
not easy in an environment where sometimes quite reasonable skepticism toward certain aspects of the industry spills over
to areas where skepticism is unfounded. Nor is it aided by political fear-mongering and painting the food industry as an
underhanded adversary just waiting to deceive unexpecting
consumers.
political fear-mongering
especially the unknown, unlikely, but not impossible food
safety risk. On the other hand, it is a shot underwater for the
free movement of goods and possibly also for innovation.
In a changing media environment with faster and better
access to information, dietary advice is, to a large extent user(read: consumer-) generated. For example, protein is the SweThe food we eat is supposedly safe. Ingredients have been
dish so-called “millenials’ poison”, because they tends to consuscrutinized, tested, and only then permitted for use in food. So me products with high protein content for health reasons –
shouldn’t that be sufficient? Should the Member States really
well, maybe not so much. Surely if this trend continues, kidney
be able to stop goods in transit at their borders for whatever
and liver problems will be frequent in their generation. “Free
reasons – be they good and sound, politically-motivated,
from” or “rich in” gluten, lactose, sugar, fat, carbs, etc. are also to
unsubstantiated, or a fear of the electorate? Socioeconomic or a large extent consumer-generated diet advice. Kids today
agricultural reasons are a bit fluffy.
don’t want to be told what to do – when did they ever? –
hence the dominance of social media as an information sourHealth claims for food might not be the key to a higher stance. Also, food choices are part of their lifestyle – they send a
dard of physical fitness in our countries, but they do provide
message about who the person is. So parents, if you are misimportant information to a consumer planning an overall
sing your kids at the breakfast, lunch, or dinner table, get used
healthy diet. How would you find the right products without
to it. But changes in how information is spread also must be
claims there to guide you? Is it really to the consumers’ benefit considered and methods adapted accordingly.
when the law creates an environment where companies
resort to permitted, but from a health perspective dubious,
Information, information, information – it might be the silver
claims? Most people in the EU don’t need added vitamins or
bullet. But is the law conducive to industry efforts? Are consuminerals in their diets, so whether consuming fortified foods
mers susceptible to misinformation? The times they are-awill maintain whatever function you chose them for is questi- changing… but then again, they always are.
onable. There is little doubt the legislature and the regulatory
system play major parts in this debate despite the fact that
health claims are voluntary.
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Compliance in the food industry?
Minimising liability by regulating conduct.
A critical evaluation
Authors: Alfred Hagen Meyer & Anna Märtlbauer | meyer.
“Compliance”
Compliance is a well-known buzzword
Compliance is a well-known buzzword. An increasing number
of seminars are appearing on the topic, for the food industry
and otherwise. Large law firms earn a pretty penny by alighting on food businesses like grasshoppers and pointing out
what they need to do to bring their business fully into conformity with the law. The word “compliance” denotes – to put it
modestly – an organisational system that operates to guarantee a company’s adherence to both legal standards and internally promulgated rules. Such systems are of primary importance when establishing and delegating (individual) responsibilities, but they do not necessarily correlate with quality
management systems.
QS & Product Safety
The terms used to describe (organisational) systems currently
in use include QA or Quality Assurance (in German QS, or
Qualitätssicherung) and “risk evaluation” or “product safety” –
the latter involving the methodical assessment of risks and
enactment of consequential control measures such as product
recalls.
Obligations
Quality assurance measures are essential for food business
operators. On account of their fundamental role in the food
chain from producer to consumer, and particularly in guaranteeing food safety (Art. 14 EC Basis Regulation 178/2002), food
businesses must actively participate in the application of (i.e.
“fulfill”) food law requirements in all respects, at all (!) stages of
production, processing, and operation, as well as verify their
compliance. The European Commission enumerated their core
responsibilities in an informational flyer entitled “Key Obligations of Food and Feed Business Operators” (19.1.2006): in
addition to safety, concerns include hygiene (EC Regulation
852/2004 on food hygiene and EC Regulation 853/2004 on
food hygiene for products derived from animals), hazard prevention (HAACP), product traceability (Art. 18), and immediate
measures under Art. 19 (returns, recalls).
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.
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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.
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Chain and Step Responsibility
[Discussed in detail by Meyer in Meyer/Streinz, LFGB –
BasisVO – HCVO Kommentar, 2. Aufl. 2012, BasisVO Art. 17,
Rn. 1-46 (in German only)]
chain responsibility
Each party in the chain of food production from farming to
final sale has a legal duty, subject to its actual and attributable
capacity, to ensure that the quality and labelling of food products meet the requirements of all applicable food laws (chain
responsibility; ECJ, 23.11.2006, Lidl Italia Srl / Comune di
Arcole, Rs C-315/05). Therefore each food company must
ensure that its goods that are faultless; no efforts or costs may
be spared in guaranteeing compliance with the requirements
of all applicable laws.
© Fischermans Friend
differentiated step responsibility
However, the particular demands on each individual business
involved in food commerce can and must vary depending on
the participant’s position in the production chain (differentiated step responsibility). Thus the duty to inspect is substantially more demanding in comprehensiveness, type, and form
for a processing plant than for a retailer. Art. 17 para. 1 Basic
Regulation 178/2002 reflects this notion by stating that food
business operators are only responsible for factors within their
control (“relevant to their activities”).
In light of the increasing interaction of growers, producers,
and distributors – for example when producers and distributors create contractual obligations that require goods to meet
specific quality and/or safety standards, or when contractors
produce foods that have conceptual and compositional properties stipulated by their distributor-contractees before production – regulatory authorities increasingly often determine
that companies share responsibility with those before and
after them in the production process. Thus it will eventually
become insufficient for each company to fulfill and verify
compliance with legal requirements within the scope of its
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.
own activities. Rather, verification should no longer be confined to each “step”, but should ensure that the previous link in
the food chain applied and fulfilled the requirements of the
food law during its activities as well.
The “secondary” responsible party (e.g., a retailer) must therefore double-check whether the “primary” responsible party (e.g.,
a manufacturer) “completed its homework”. The review may
entail monitoring and evaluating customer complaints and
other problem indicators (esp. of suppliers, but also RASSF
alerts and other recalls), conducting on-site audits and systematic analysis of their results (e.g. of suppliers) and of the consistency and suitability of quality assurance measures enacted
(increasing quality and safety requirements by way of adjusting specifications, improving control procedures, and/or discontinuation).
“Old doll in a new dress”
What is now called “compliance” is therefore nothing more
than the “old doll in a new dress”, namely, beginning with the
prior link in the chain, an internal company process for the
evaluation of (newly acquired) knowledge and implementation of quality control measures, which can be paraphrased as
• Handling instructions/Task or job descriptions (compliance guidelines)
• Effective implementation of such instructions
• (Concrete) risk analysis (case-by-case)
• Exercise of due care (case-by-case)
• Monitoring and review of past issues.
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Corporate liability
A food business operator’s adherence to legal standards by
enforcing internal corporate rules (whatever one chooses to
name this method) is imperative to minimizing and possibly
even completely avoiding corporate liability issues.
“regulatory fine”
This is the case with respect to the so-called “regulatory fine”
set forth in section 30, para. 1 of Germany’s Act On Regulatory
Offences or OWiG (§ 30 para. 1 OWiG). Under this provision,
regulators may fine a company if certain company leaders or
organs (i.e. authorized agents of a legal person, § 30 para. 1 Nr.
1 OWiG) committed a crime or regulatory violation that resulted in a breach of the duty of care or the enrichment or intended enrichment of the legal person.
§ 30 OWiG applies to all types of companies, including food
businesses. For example, if an organ of a company that is the
company’s authorized representative fails to issue a necessary
product recall, not only will that organ be held accountable
for the failure, but also a fine may be levied against the food
company as a whole in accordance with § 30 para. 1 OWiG.
Since the ratification of a 2013 legislative amendment to the
Act Against Barriers to Competition (BGBl. I 2013, p. 1748 v.
29.06.2013), a regulatory fine under § 30 para. 2 OWiG can
amount to up to 10 million euros for an intentional violation
or up to 5 million euros for a negligent violation. Before the
amendment, fines were capped at 1 million and 500,000
euros, respectively. The calculation for penalties under § 30
OWiG therefore highlights just how important it is that a business takes appropriate organizational precautions to ensure its
organs and employees strictly uphold the company’s duties in
accordance with the law. In this sense, § 30 OWiG basically
“demands” that companies have in place an effective compliance system to internally prevent criminal and regulatory violations.
Pre- and post-violation conduct and exculpation
Such a compliance system – or better yet, QA system including risk evaluation and management – can not only minimize the risk of unsafe foods reaching the market, but in the
event of an isolated error, create a path to exculpation from
criminal and regulatory penalties.
Although not codified in Germany as in for example in the
United Kingdom’s UK-Bribery Act UKBA, there are principles
gradually taking shape within the frameworks of regulatory
and criminal law that reflect that prosecutors might weaken or
even waive sanctions against a business that had sufficient
compliance procedures in place to prevent criminal and regulatory infractions (by employees) prior to the violation at hand.
If the company’s sufficient internal requirements were in fact
met and this can be verified by a third party, the business can
minimise risks, particularly those that arise under the “inclusive
model” of § 30 OWiG (Regulatory fines against legal persons
and organisations), and simultaneously prevent its employees
from running afoul of the criminal law.
Currently § 30 para. 1 OWiG includes no such explicit possibility of exculpation. Also in the context of the above-mentioned
amendment affecting § 30 OWiG in 2013 (BGBl. I 20123, p.
1748), no such exculpatory provisions were added to the normative text even though the German Bar Association for
example expressly requested their inclusion (see position
paper Stellungnahme Nr. 75/2012 des Deutschen Anwaltvereins from the Committee on Criminal Law’s draft law proposing changes to the Act On Regulatory Offences, September 2012).
effective compliance system
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Nevertheless, the existence of an effective compliance system
may be taken into consideration in the context of setting
fines, as shown in the legal justification for § 30 OWiG. Under
what circumstances and to what extent a satisfactory compliance system will warrant a fine decrease is a matter for the
regulatory agency or court to determine on a case-by-case
basis (BT-Drs. 17/11053, S. 21). If nothing else, it is at least
clear that authorities can consider an existing compliance system as a factor when setting fines – notwithstanding the continued lack of differentiated fine setting rules, despite the fundamental principles of the rule of law that would seem to
mandate regulation of this type of compensation.
In any case, investigative authorities in both regulatory and
criminal procedures (usually) pay adequate attention to the
principle of recognition of the offender’s conduct before and
after the fact; under German criminal law, this is fairly common
in the context of so-called “deals” based on (Criminal Procedure Law) § 257c para. 1 StPO (“In suitable cases the court may,
in accordance with the following subsections, reach an agreement with the participants on the further course and outcome of the proceedings”).
Pre- and post-violation conduct and rules
regarding the imposition of penalties
If the existence of an internal company QA procedure and its
active and effective implementation does not prevent or minimize sanctions, punishments nevertheless may be reduced on
an individual basis as a result of good post-violation conduct.
Here, too, the applicable regulatory offence law does not provide government agencies and courts with any standard as to
how to treat the harm-mitigating efforts of a business before
and after a violation. By contrast, under the criminal law each
penalty determination requires the application of § 46 StGB
(fundamental principles of criminal sentencing: “When sentencing the court shall weigh the circumstances in favour of and
against the offender. Consideration shall in particular be given
to […] the offender’s conduct after the offence”). For a
regulator’s imposition of steep financial penalties on the other
hand, the OWiG has no such rules to date; an analogous application of § 17 para. 3 OWiG is also not permitted (“The significance of the regulatory offence and the charge faced by the
perpetrator shall form the basis for the assessment of the
regulatory fine”).
In actual regulatory enforcement procedures against companies, often the subject companies are either practically forced
to cooperate with the agency’s prosecutors and/or they support the agency’s involvement in order to curtail potential
misconduct of certain employees in the future. Cooperation
may entail for example a company resolving a known issue
first internally, and then presenting both the problem and the
solution employed to the regulatory authority.
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 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
Research Centre for German and European Food Law in
Bayreuth and chairman of the administrative board of the
German Nutrition Society (DGE).
Practice additionally shows that in financial penalty procedures against companies it is (or should be) possible to obtain a
reduction or waiver of a fine by cooperating during the investigation and subsequent compliance efforts in the sense of
post-violation conduct, particularly through the elimination of
known weaknesses in the company structure.
One example of a practical legal model for the above-mentioned mechanisms can be found in German antitrust law. There, detailed rules for setting financial penalties are set forth in
the “Guidelines for the setting of fines in cartel administrative offence proceedings”, published by the German Federal
Cartel Office (BKartA, 25.06.2013). Point 18 of the guidelines
allows for positive post-violation conduct to be separately
taken into account at the fine setting stage if the business files
an application for leniency (or a “bonus”). Detailed implementation rules for the amounts of these bonuses can be found in
the Federal Cartel Office’s Leniency Notice Nr. 9/2006 (“on the
immunity from and reduction of fines in cartel cases”, BKartA,
25.06.2013). The specific post-violation conduct described in
that document, namely, supporting the Federal Cartel Office
in uncovering cartels, can result in a reduction or even complete waiver of the fine.
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CJEU Ruling On Health Claims
Author: Anne-Marie Taylor | dwf
Few Regulations have created as much upheaval for the food
industry as Regulation (EC) No 1924/2006 on Nutrition and
Health Claims (‘HCR’). The Health Food Manufacturers’ Association (‘HFMA’), which represents manufacturers and suppliers
of health products in the UK, along with other trade groups
including Natuur-& gezondheidsProducten Nederland (‘NPN’)
in the Netherlands, is the latest group that attempted to challenge the maelstrom caused by the HCR at the Court of Justice of the European Union, but their action was dismissed in its
entirety on 12 June 2015. We take a look at the case and the
implications for food businesses.
Background
Only authorised health claims included in the list of permitted
claims (‘the permitted list’) can be made on food. The permitted list is established under Commission Regulation (EU) No
432/2012.
In the process of compiling this permitted list, the Commission received an overwhelming 44,000 health claims for consideration from Member States. After streamlining these claims
into a consolidated list, removing duplications and repetitions,
4,637 health claims were referred to EFSA for scientific
assessment.
Only 222 (around 8%) of the claims assessed received a positive opinion and were authorised to be placed on the permitted list by the Commission on 16 May 2012.
health claims “on hold”
That same day, the Commission also published a list of more
than 2000 claims that either EFSA had not finished assessing
or that the Commission had not yet considered (‘the on hold
list’), almost all of which related to botanical substances (save
for some relating to caffeine, lactose and very low calorie diet).
These on hold claims can still be used as long as they comply
with the transitional provisions under Article 28(5) and (6) of
HCR, which, in the UK at least, is interpreted to mean compliance with Articles 3,5,6,7 & 10 of the HCR.
Basis of Case T296/12
The action of HFMA, NPN and others (‘the Applicants’) related
to the unlawfulness of Regulation 432/2012 and the on hold
list and extensive submissions were made in relation to lack of
legal certainty, good administration and non-discrimination.
The key grounds and the Court’s Judgment are:
1. Application for annulment of Regulation
No 432/2012.
The Applicants argued that there was:
‘a lack of legal basis and an infringement of the principles of legal
certainty, good administration and non-discrimination when
adopting the decision to split the authorisation procedure for
health claims into several stages…
an infringement of the principle of good administration, the principle of legal certainty and the duty of collaboration with national
food authorities, as well as the obligation to state reasons when
not including a large number of health claims in the list of permitted claims.’ (T 296/12, par 52)
As part of the legal uncertainty complaint, the Applicant highlighted that food businesses could not easily identify the
claims that were on hold; a concern seemingly echoed by the
UK’s Department of Health which felt compelled to publish a
bulletin on the topic on 16 April 2014 indicating that determining on hold claims was a ‘difficult task’.
The Applicants also contended that EFSA’s evaluation methodology was flawed, for example, by requiring a ‘significant’
beneficial effect, which goes beyond the Article 5 criterion for
‘a’ beneficial effect, and that the it was to apply criteria was not
available until after the national lists were drawn up .
Further, the requirement that health claims are ‘well understood by the average consumer’ is not always reflected by the
Commission in the approved claim wording which is often
complex and scientific.
The Court was not persuaded and concluded that the adoption of the permitted list in several stages does not result in the
adoption of several lists, but rather a single list which is added
to gradually and it agreed with the Commission that waiting
for completion of the assessment of all claims would have
delayed the objectives of HCR even longer.
It concluded that only Member States were empowered to
provide the Commission with national lists of health claims
intended to form the basis of the permitted list and the Commission was not required to consult with food businesses
when devising the procedure for compiling the permitted list.
The websites of the EFSA and the Commission make the consolidated list of claim ID codes and the list setting out the ID
codes of those claims on hold (as well as rejected) available to
the public.
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There was no evidence that the level of scientific substantiation required in the guidelines subsequently adopted by the
EFSA was not expected when the national lists were drawn up.
2. Application for a declaration, indirectly and
on the basis of Article 277 TFEU, that Regulation
No 1924/2006 is inapplicable.
application meant that a claim otherwise capable of scientific
substantiation was rejected. Further, by clustering similar
health claims and health relationships, the meaning and
practical application of some has been lost and the ultimate
approved claim wording either does not reflect the intended
claim or makes no sense to the average consumer.
While it may seem reasonable that on hold claims can be used
under the transitional measures, in practice, this leaves uncertainty for food businesses. The list of on hold ID codes may
• Article 13(3) of HCR infringes good administration and
well be public, but this pattern of numbers does not assist the
their right to be heard. In particular, the authorisation
average reader to find the appropriate claim wording. Indeed,
procedure should have enabled food businesses to
even if the claim wording is found, some ‘on hold’ claims were
submit comments on claims of interest to them, partisubmitted to EFSA in different languages, so it is unclear what
cularly before the EFSA.
translation should be used for such claims. Even if the langua• HCR infringes the principle of legal certainty as Articge is fairly clear, is difficult to know with certainty whether a
le 28 does not lay down reasonable transitional periclaim meets the scientific substantiation requirements of
ods (particularly for foods with long shelf lives) and the Article 6 of HCR, particularly where there is no conclusive opiscope of the review required to authorise health
nion of EFSA. Then even where there is a negative opinion, if
claims under Article 13(3) was not clearly defined.
a food business possesses substantiation which is superior to
• The Court disagreed and found that the adoption of
that considered by EFSA it is unclear whether this would be
Regulation No 432/2012 was preceded by a public
acceptable to competent authorities, particularly if there is
consultation stage during which FBOs, including the
divergent opinion between a particular Member State and
Applicants, had the opportunity to express their views EFSA.
and therefore the complaint must fail.
Where businesses market products across the EU, the applicaSimilarly, the HCR did not aim to prohibit the marketing of the bility of national provisions adds an extra layer of uncertainty,
Applicants’ goods in the entirety, but merely to have unautho- which may require them to incur the cost of legal advice in
rised health claims removed from labelling of those goods.
individual Member States.
The Applicants argued that:
3. Application for annulment of the on hold list.
The substance of this application was not heard because it
was held to be inadmissible on the basis that the on hold list
was ‘merely an interim measure which does not have any
regulatory or decisional content and which is therefore not
capable of altering the legal situation of the applicants.’
(T296/12, par 199).
The risk is that the inflexibility of the HCR results in an insipid
EU marketplace that struggles to compete with the more
colourful claims made on food products overseas and we fear
that the consumers may be the ones that lose out in the end
as they are driven to potentially unreliable information on the
internet to inform their decisions to purchase ‘health’ foods.
Implications for Food Businesses
This is a disappointing outcome for food businesses, particularly those that rely heavily on botanical ingredients, such as
the food supplement industry. While essentially the judgment
does not change the health claim position, it does seem to
rubber stamp the Commission’s unsatisfactory approach to
health claims, meaning they are likely here to stay unhindered.
Anne Marie Taylor
Senior Solicitor
Tel: +44 (0)20 7645 9564
Mob: +44 (0)7921 397 632
Email: annemarie.taylor@dwf.co.uk
disappointing outcome for food businesses
The incredibly high rejection rate remains unexplained; albeit
a key factor is likely that EFSA were only permitted to assess
the information supplied with the claim application; so a poor
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Composition in focus in the UK as the
health agenda is a central focus
Authors: Dominic Watkins and Anne-Marie Taylor | dwf
In recent years in the UK considerable focus has been put on
the composition of food and the role that food manufacturers
have to play in the health agenda. Many food manufacturers
have already signed up to a “Responsibility Deal” which sees
food business reducing the levels of fat, sugar and salt and for
many years there has been specific rules restricting the advertising on TV of those products that are high in fat sugar or salt
from being advertised at times that are populate with children. With an eye on similar schemes in other states, fat and,
more recently, a sugar “tax” on foods high in either has gained
popularity in the media.
“Responsibility Deal”
There is no doubt that there is support for a sugar levy, including from organisations such as the British Dental Association
as well as senior figures in the Department of Health, but
while a debate about how to reduce sugar intake is to be welcomed, experience in Denmark suggests that sugar tax regimes alone are ineffective.
It is clear from the Scientific Advisory Committee on Nutrition’s
recent draft report on carbohydrates that UK consumers need
to reduce the sugar in their diet. Taking this into account, Public Health England has published actions that the government
is taking and proposes to take to help reduce sugar intake.
This action is a mixture of public engagement, promoting
‘sugar swaps’ and educating families on making healthier
choices, and dialogue with industry about what they can do.
Customer demand for healthier options has meant that industry is already responding by reformulating recipes to ween us
In recent months, celebrity chef, Jamie Oliver, has become
of sugar, offering smaller portion sizes, low sugar product ranone of the loudest campaigners for a tax on sugary drinks, and ges and resealable packaging, providing front of pack labelling
launched an online petition calling for a 7p tax per regularand restricting promotions on sugary foods.
sized can of soft drink with added sugar. The proposal calculates that this would generate £1 billion per year that could be
The tide has turned and we are moving towards greater reguring-fenced to support preventative strategies dealing with
lation of the advertising of these products across all media. To
childhood obesity and diet-related disease.
underline this point, on 29 September 2015 the Committee of
Advertising Practice (which sets the UK advertising rules)
The petition has received over 144,000 signatures so far, which announced a consultation on extension of the rules restricting
is in excess of the 100,000 signatures required for a topic to be the advertising high fat, sugar and salt products in non-broaddebated in Parliament, however, the Department of Health
cast media, read the consultation here: http://ow.ly/SMNtJ
has responded by publishing the following statement:
The Government has no plans to introduce a tax on sugarsweetened beverages.
The Government has committed to a tax lock to avoid raising
the cost of living and to promote UK productivity and economic growth, however, the Government keeps all taxes under
review, with decisions being a matter for the Chancellor as
part of the Budget process.
The causes of obesity are complex, caused by a number of dietary, lifestyle, environmental and genetic factors, and tackling
it will require a comprehensive and broad approach. As such,
the Government is considering a range of options for tackling
childhood obesity, and the contribution that Government,
alongside industry, families and communities can make, and
will announce its plans for tackling childhood obesity by the
end of the year.
People should have the choice to eat or
drink what they like
It will be interesting to see what comes out of the sugar debate, but it is important not to lose sight of the fact that it is not
‘healthy’ to cut any one nutrient out of the diet entirely. People should have the choice to eat or drink what they like, but
the education to know when to eat or drink it in moderation.
A sugar tax alone cannot achieve this.
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10
In brief
Author: Dominic Watkins | dwf
Political change could see vast changes
as devolution agenda gains pace
proposal for regional areas or Mayors being given the power
to determine whether shop opening hours on a Sunday
should be extended from the current six consecutive hours
within the Council’s area of control. Other power changes are
likely to follow.
Primary Authority extension
As part of its better regulation agenda, the UK has for a number of years had ‘Primary Authority’ relationships between the
regulated and the local regulator. These relationships were initially aimed at multisite businesses operating across the UK
which meant that they were being regulated by dozens and
sometimes hundreds of different local regulators, each of
Given the way that the referendum on Scotland remaining
which could, in theory at least, make a different decision
part of the United Kingdom was conducted and how close
about the same issue. The Primary Authority solved that probthat this vote was feared to be, there is considerable concern
lem by taking the lead on these issues and providing a single
that the public at large may be swayed by a very vocal “out”
point of contact for the enforcement community. It is also
lobby. This has led to the UK Prime Minster, David Cameron,
able to produce ‘assured advice’ on particular issues which is
seeking to renegotiate the terms of membership of the EU.
then effectively protected against challenge by other regulaThe success of this negotiation remains to be seen but it has
tors without the Primary Authority’s permission. Primary
put a huge focus on the role the UK will play in the EU in years Authority has been of great interest to the EU which has
to come, and given the EU is the origin of almost all food law
repeatedly expressed a desire for exploring how the scheme
it is a key issue to follow.
could be extended across member states.
A central manifesto pledge of the new government is an “in or
out” referendum on EU membership. This means that in the
next two years the UK people will decide whether or not they
wish to be a part of the EU, or not.
The Primary Authority scheme has been very successful and at
present is subject to a consultation, as a part of the Enterprise
vocal “out” lobby
Bill, allowing for the entire regime to be redrafted to allow for
greater simplification of the scheme, the extension to other
areas of legislation and making it easier for many other businesses to benefit. In particular these include making it easier
The second big change in the election was the sweeping to
for smaller businesses to join through automatic membership
power in Scotland of the Scottish National Party. This is signifi- through trade associations and easier to extend the Primary
cant as not only did it see some former Ministers in the last
Authority scheme.
Government lose their place in Parliament to unheard of SNP
candidates but it came a matter of months after the SNP lost
the referendum which saw Scotland narrowly vote remain
part of the UK. Now, with the assent in power of the SNP, the
SNP has not ruled out pushing for a further referendum on
Scotland’s membership in the UK and in the interim is obtaiDominic Watkins
ning greater devolved power to legislate.
Partner - Head of DWF’s internationally
The consequences of the Scottish referendum are not just
renowned food sector group as well as
being felt in the relationship between England and Scotland,
being Head of Regulatory in London.
it has had broader consequences and expedited the devolution agenda considerably. It is already the case that the UK’s
Tel: +44 (0)207 645 9591
implementing regulations for much of EU law comes in an
Mob: +44 (0)7734 508634
English, Scottish and Welsh version which contains some subtEmail: dominic.watkins@dwf.co.uk
le, but significant differences. As further powers are devolved
to those regional parliaments it is increasingly difficult to
determine how to comply as it is becoming less common for
there to be a one size fits all solution.
The devolution debate has then been extended further as
there are proposals to devolve more power to Mayors of large
cities like London or regional assemblies. The exact scope of
the proposal remains to be seen but already we have seen a
dwf the legal business where legal expertise, industry
knowledge and leading-edge technologies converge, helping your business go further.
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11
TURKEY – recent developments in
relation to the use of genetically modified
organisms
Authors: Kayra Üçer & Candan Çırnaz | Hergüner - Bilgen - Özeke
Biosafety Law No 5977 (the “Biosafety Law”), which entered
into force on 18 March 2010, was the culmination of years of
efforts towards preparing legislation to govern transgenic
plants, dating back to 1998. The Biosafety Law aims to minimize risks that may be posed by genetically modified organisms
(“GMOs”); preserve human, animal and plant life; establish a
biosafety system; and regulate and monitor related actions. As
per the Biosafety Law, GMOs and their products (i.e., products
obtained partially or completely from GMOs, products with
GMOs, or products consisting of GMOs) can be used, imported, exported, or introduced to the market following the risk
assessment and approval of the Biosafety Board, which will be
valid for a term of 10 years from its issuance.
Regulation on Genetically Modified Organisms and Their
Products (the “Regulation”), which entered into force on 13
August 2010, aims to regulate the use of GMOs in more detail,
such as by indicating how applications are to be assessed, setting thresholds for GMOs, and specifying how compliance
with such thresholds is to be monitored.
Threshold for labelling:
In accordance with the Regulation, if the amount of the GMOs
within a product is below the threshold, then the label of the
product is not required to indicate that the product contains
GMOs. Only products that contain GMOs above the threshold
are required to state the fact that they include GMOs on their
label. Accordingly, the threshold in relation to GMOs gains
importance as the labelling requirement depends on the
threshold.
0.9% threshold
In 2014 the Regulation in Turkey was slightly amended, and it
introduced the concept of GMO contaminants or GMO traces
in line with the EU Regulation. As thus amended in 2014, the
Regulation refers to GMOs below 0.9% in a product as GMO
contaminants or GMO traces. However, unlike the EU Regulation, the relevant legislation in Turkey does not set this
threshold for the labelling requirement, and leaves the
threshold for labelling requirement to the discretion of the
Biosafety Board and the Ministry of Food, Agriculture and Livestock (the “Ministry”). Although the relevant Regulation does
not refer to a specific threshold for labelling, up until now the
Biosafety Board in its decisions has resolved the labelling
requirement in line with the EU threshold, at 0.9%.
Kayra Üçer
Kayra Üçer is a partner in the Corporate Department of Hergüner Bilgen
Özeke. Mr. Üçer provides clients with
legal assistance in corporate and commercial matters, including among
other areas of expertise, mergers and
acquisitions, labor law, compliance law
and anti- corruption practices.
The EU Regulation on the same subject sets the threshold at
0.9%, and puts into place a labelling requirement for products Restriction on the use of GMO beyond EU Regulation
containing GMOs above such threshold (Regulation (EC) No
1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed
“zero tolerance”?
products produced from genetically modified organisms). The
EU Regulation exempts products containing GMOs below the
threshold from the requirement to state on their label that
they contain GMOs, providing that these traces may be adventitious or technically unavoidable; GMOs below the threshold The amendment of 2014 caused a public backlash, as “zero
are considered as GMO contaminants or GMO traces.
tolerance” was the approach previously adopted towards
GMOs. With the amendment of 2014, it became possible to
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12
consider GMOs to be GMO contaminants if they made up less
than 0.9% of a product, and if these GMO contaminants were
approved by the Biosafety Board, then it would be free to use
them. This meant that the restriction against the use of GMOs
would not be applicable for GMO contaminants. For instance,
under the Regulation it is illegal to use GMOs in baby food
and nutritional supplements of babies and small children, but
this restriction does not apply to GMO contaminants.
The Biosafety Board has not yet approved any GMOs for food
purposes. The Biosafety Board has approved GMOs for animal
feed only. In accordance with the recent explanations provided by the Biosafety Board Deputy Chairman, even if a product contains GMOs of less than or equal to 0.9%, and even if
such GMO is approved by the Biosafety Board, it can only be
used for animal feed, not for food. Accordingly, although it
seems that the Regulation paves the way for the use of GMOs
below 0.9%, this is indeed not the case. The Turkish GMO regulatory approval system holds the unique distinction of being
the only system in the world that does not approve GMOs for
food use: even the EU operates a GMO regulatory regime that
approves GMOs for use in both food and animal feed.
Breach of relevant legislation
In case of a breach of the provisions of the Biosafety Law, the
following sanctions may be applied, among others:
• If GMOs and/or their products are imported, manufactured or left in the environment in breach of the Biosafety Law, the guilty party may be imposed a prison
sentence of five to twelve years, and a monetary fine
of up to 10,000 days, which corresponds to a monetary sanction between TL 200,000 (approx. Euro 58,508)
and TL 1,000,000 (approx. Euro 292,540).
• If GMOs and/or their products are used, sold or transferred for purposes other than those stated in their
import permits, the guilty party may be imposed a prison sentence of four to nine years, and a punitive fine
up to 7,000 days, which corresponds to a monetary
sanction between TL 140,000 (approx. Euro 41,000)
and TL 700,000 (approx. Euro 205,000). Any person
who purchases, accepts, transfers or keeps such products while knowing about this breach may also be
subject to the same sanction.
• If a party makes a false statement when filing an application to obtain approval from the Biosafety Board for
importation or processing of products obtained from
GMOs, then the guilty party may be subject to a prison sentence of one to three years.
• If the offenses stated above are committed pursuant
to the activities or for the benefit of a legal entity, then
such legal entity may be imposed an administrative
fine of TL 100,000 (approx. Euro 29,255) to TL 200,000
(approx. Euro 58,508), and the legal entity may also be
subject to security measures (e.g. cancellation of existing license, etc.).
Candan Çırnaz
Candan Çırnaz is an associate in Corporate Group of Hergüner Bilgen
Özeke Attorney Partnership. Ms. Çırnaz
practices all aspects of legal advice in
general corporate law also participated
in mergers and acquisitions. Apart
from this, Ms. Çırnaz practices all
aspects of employment and commercial law related issues as well.
Hergüner | Bilgen | Özeke
Hergüner Bilgen Özeke is one of the largest, full-service
independent corporate law firms in Turkey, representing
major multinational and local corporations and clientele,
and international and multilateral financial institutions
and agencies. Hergüner not only provides expert legal
counsel to its clients, but also serves as a trusted advisor
for them and provides premium legal advice within a
commercial context.
Our team is currently comprised of approximately 100
attorneys, most of whom have completed their education
abroad, and approximately 45 support staff, making it one
of the largest law firms in Turkey.
Major practice areas include: corporate/mergers and
acquisitions, banking and finance, capital markets, project
development and project finance, Infrastructure and PPP,
competition, employment, intellectual property, dispute
resolution and commercial and real estate in sectors and
industries such as: telecommunications, oil & gas and
energy, media and technology, automotive, aviation and
transportation.
Büyükdere Caddesi 199 Levent
34394 İstanbul TÜRKİYE
T +90.212.310 18 00
D +90.212.310 18 87
E-Mail: edenizel@herguner.av.tr
www.herguner.av.tr
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13
Recent decisions of the Austrian
regional administrative courts relating
to food law matters
Author: Eva Maria Kostenzer I Schönherr
Ute Reindl
Storage conditions for honey
Landesverwaltungsgericht Tirol, LVwG-2013/23/0488-13,
Decision dated 28.01.2015
Landesverwaltungsgericht Oberösterreich, LVwG-000070/2/
WE, Decision dated 14.01.2015
The proceeding concerned a fine imposed for selling vacuumpacked fresh turkey breast that exceeded the maximum tolerance for Salmonella typhimurium set out in Reg. (EC)
2073/2005. As manager of a branch of a company trading in
the food retail sector, the appellant was responsible for compliance with all applicable food safety laws. The turkey breast
was produced and packed by another company.
The regional administrative authority claimed that the storage
conditions for the prepacked foodstuff “liquid honey” were
insufficient because the product could only be considered
durable until the indicated date when the product had been
“stored protected against warmth.” The authority therefore
imposed a penalty on the responsible person of the retail
establishment that sold the product to the consumer.
The regional administrative court requested a preliminary
ruling from the ECJ for guidance on the interpretation of Reg.
(EC) 2073/2005, specifically, to what extent food business
operators that are active only in distribution of a product may
be liable for its non-compliance with the regulation.
The ECJ answered that the microbiological criteria for fresh
poultry meat mentioned in Reg. (EC) 2073/2005 must be
satisfied at all stages of distribution, including the retail sale
stage. Furthermore, EU law does not preclude national law
from penalizing a distributor for failing to comply with the
microbiological criterion laid down in Reg. (EC) 2073/2005
when placing a foodstuff on the market. It is for the national
court to determine whether the penalty at issue adheres to
the principle of proportionality (ECJ, Case C-443/13, decision
of 13.11.2014).
monetary penalties guarantee the
protection of health
The regional administrative court subsequently determined
that the relevant national provision is proportionate because
monetary penalties guarantee the protection of health, and
the provision at issue is an appropriate means of achieving a
high level of public health protection. In the court’s view, the
appellant could not prove that she was not at fault for the violation. The court affirmed the penalty and dismissed the
appeal.
MMag. Eva Maria Kostenzer, LL.M.
Associate, Schönherr Rechtsanwälte GmbH
Eva Maria Kostenzer has been an associate at Schönherr
in Vienna since 2012. She specialises in European and
Austrian food law, product law and litigation. She regularly acts for Austrian
and international companies in civil
and administrative law proceedings.
Before joining Schönherr, Eva Maria
was a member of the academic faculty
at the Department of European Law
and Public International Law, University of Innsbruck, Austria. She publishes
regularly on Austrian and European
food law.
schönherr rechtsanwälte gmbh
schoenherr attorneys at law
schottenring 19
A - 1010 vienna, austria
t: +4315343750342
f: +435343766151
Email: e.kostenzer@schoenherr.eu
www.schoenherr.eu
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14
Schönherr is one of the leading legal firms in CEE region with exciting but also
very complex markets that remain in transition. Our knowhow edge in this region, our optimally positioned company structure, and our distinguished local contacts and networks provide our clients with a decisive competitive
advantage. Here’s an overview of facts & figures for
schoenherr.
According to the regional administrative court, the storage
conditions were indeed insufficient. Even under the assumption that liquid honey can be stored for a long time at room
temperature, a storage condition such as “store protected
against warmth” is essential because honey is heat-sensitive
and a rise in temperature, for example caused by direct sunlight, may lead to a loss of valuable properties such as aroma,
enzymes and vitamins. Accordingly, correct observance of storage conditions is prerequisite to ensuring that consumer product purchases have the properties that determine the value
of the product for its shelf life. This obligation results from Section 4 para. 1 no. 6 LMKV as well as Art. 4 para. 1 lit. b) sublit. ii)
Reg. (EU) 1169/2011 (“FIC”).
business operator whose functions do not affect food information is only responsible for compliance within the limits of
its professional activity. It shall not supply food which it knows,
or may presume on the basis of information in its possession,
to be in violation of applicable European and national food
information laws. The court found that a responsible party
may rely on the correctness of such certificates and was not
obliged to make additional inquiries. As the retailer’s activities
did not affect the product information and the retailer did not
possess other information, it could defer to the responsibility
of the producer with regard to labelling.
„Semmelbrösel“
Landesverwaltungsgericht Wien, VGW-101/027/3487/2014,
Decision dated 29.10.2014
This administrative criminal law proceeding concerned the
question whether the ingredients of breadcrumbs, which
were used itself as ingredient for a prepacked roast made of
minced meat, have to be indicated on the label or not.
The regional administrative court of Vienna stated that according to Section 4 para. 1 no. 7 lit. b) Austrian LMKV (now
Annex VII part B FIC), it is permissible to use the name of the
category listed in Annex I instead of the specific name for certain ingredients. Accordingly, the designation “Brösel” or
“Paniermehl” (“breadcrumbs”) may be used for all types of
crumbed, baked cereal products. Furthermore, according to
essential labelling “store protected
Section 4 para. 1 no. 7 lit. e) Austrian LMKV (now Annex VII
against warmth”
part E FIC) a compound ingredient may be included in the
ingredients label under its own designation as long as a list of
its component ingredients immediately follows. According to
In the case at hand, however, the person in charge of the
the court these provisions do not apply in parallel because lit.
retailer’s compliance with the food law could not be held res- b) constitutes a lex specialis to lit. e); otherwise there would be
ponsible for this infringement of labelling provisions. The com- no potential application of lit. b).
plainant submitted three marketability certificates from laboratories accredited by the Ministry of Health that had been
issued prior to his inspection. The marketability certificates
“Brösel” or “Paniermehl” (“breadcrumbs”)
additionally indicated the product’s compliance with applimay be used for all types of crumbed,
cable labelling regulations. The court stated that the food
baked cereal products
business operator has a reduced duty to inspect goods if he
involves qualified experts. If the certificates would not obviously appear incorrect to a layperson, a further professional
As a consequence, all types of crumbed, baked cereal proexamination would exceed the standard of due care in busiducts may be labelled as “Brösel” or “Paniermehl” without indiness operations and thus cannot be a requirement.
cation of their constituent ingredients. The name “Semmelbrösel” may be used as well, as this term is mentioned in the AustThe court also pointed to Art. 8 FIC, which distinguishes resrian Food Codex (“ÖLMB”) as synonym for “Brösel” or “Panierponsibilities along the food chain. As a basic principle, foods
mehl” and is even more understandable to the Austrian
must be marketed under the name of the business responsib- consumer than “Paniermehl”.
le for providing food information. According to para. 3, a food
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15
Update on Food Law in China:
New Food Safety Law 2015
Author: Jörg-Michael Scheil I Schulz Noack Bärwinkel, Rechtsanwälte PartmbB
The revised version of the Food Safety Law of the People’s
Republic of China was adopted on 24 April 2015. It will be
effective as of 1 October 2015. This revision comes after the
latest amendment in 2009, and it follows several rounds of
drafts which were published by the government for public
comments. In light of repeated serious food scandals in China
involving misbranded and contaminated food, the drafts were
widely discussed.
from the list would make any further imports from a certain
overseas producer into China impossible. Exporters should
therefore use due caution to verify that materials and information provided, including labelling instructions, comply with
Chinese regulations. They should also check that the instructions are properly executed by their importers.
The new food safety law further develops mechanisms for the
prevention of specific risks such as food borne illnesses, illegal
additives, and other forms of contamination while also increasing the legal liability of manufacturers and food distributors.
In the following, we will focus on certain changes affecting
foreign food exporters to China.
Apart from the new safety law, the Chinese government has
also moved ahead with regard to food-related standards. On 4
August 2015, the National Health and Family Planning Commission published for public comment the drafts of 26 new
food-related standards, including inspection methods for
mineral water and a refrigeration transportation code for dairy
products.
1.Compliance guarantee of exporters
5.Dairy exports from the EU
The new law requires in Art. 94 that overseas exporters and
producers shall guarantee that the foods, food additives, and
food related products exported to China comply with the
requirements of the Food Safety Law, other administrative
laws, regulations and the national food safety standards; they
shall also be responsible for the content of the food labels and
instructions. Previously, exporters were expressly only responsible for the content of food labels and instructions.
Previous drafts of the law contained a ban on the production
of infant milk formula under contract manufacturing. This ban
has been removed in the final version of the new law, partially
due to EU lobbying efforts. In 2014, the EU exported dairy products with a value of over 783 million EUR to China, which is
about 10.5 % of all agricultural exports to China. European
exporters of dairy products should also note that under special administrative regulations, pre-packaged dairy products
imported into China must be labelled with the required information in Chinese already before import. It is not permissible
to repackage, divide or relabel the products after import.
2.Increased responsibility of food importers
The obligations of exporters are mirrored by newly added
obligations of Chinese food importers. According to Art. 94 of
the new law, importers shall establish an examination and
verification system for overseas exporters and producers. Products that fail to pass a review shall not be imported.
3.Removal from registration list
The Chinese State Administration of Quality Supervision, Inspection and Quarantine („SAQSIQ“) is in charge of safety administration and food imports and exports. According to the
new law, food additives now also follow almost the same inspection rules as imported food. Imported food and food additives shall be accompanied by relevant inspection certificates.
The new law now also requires registered overseas food producers that provide false materials or cause serious incidents
to be removed from the registration list by SAQSIQ, and for the
removal to be announced by public notice. Such removal
4.New standards
Dr. Jörg-Michael Scheil
Dr. Jörg-Michael Scheil is a German
attorney-at-law and Partner at Schulz
Noack Bärwinkel, where he has been
practicing in the Shanghai office since
1999. He advises primarily European
clients from the food industry, including food and beverage producers as
well as wholesalers and retailers, on
the Chinese market. Apart from all
matters related to Chinese food law
and standards, he also specialises in
aspects of intellectual property and distribution law.
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6.Implementing regulations in China
Schulz Noack Bärwinkel, Rechtsanwälte PartmbB
In China, the enactment of a new law requires the promulgation of implementing rules. The Chinese Food and Drug Administration is now preparing to authorize implementing regulations for the new food safety law, which will certainly be closely monitored by all market participants.
Suite 2301
2201 Yan An Road (West)
200336 Shanghai, PC China
Tel. + 86 21 6219 8370
Email: jm.scheil@snblaw.com
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17
Regulatory News
Authors: Uta Verbeek, Kerstin Baumgärtner, Brigitte Ruisinger | meyer.science GmbH
Content
1. European Food Safety Authority – EFSA
18
1.1 Food safety
18
1.1.1 Perilla aldehyde: Flavouring substance considered
a safety concern
18
1.1.2 Acrylamide in food is a public health concern
18
1.1.3 Caffeine: EFSA estimates safe intakes
19
1.1.4 Perchlorate in fruit and vegetables opinion re-published 19
1.1.5 Chlorate in food: risks for public health
20
1.1.6 GMO – New guidance for strengthening GM risk assessment 2 0
1.1.7 AOB – Updated EFSA food classification to support data
collection and aid data providers
20
1.2 Vitamins and minerals
21
1.2.1 Dietary Reference Values: Magnesium and
Phosphorus
21
1.2.2 Dietary Reference values: Vitamin E and Cobalamin
21
1.2.3 Dietary Reference Values for Calcium
21
1.2.4 Dietary Reference Values for Vitamin A
22
1.
European Food Safety Authority – EFSA
1.1
Food safety
1.1.1 Perilla aldehyde: Flavouring substance considered
a safety concern
The flavouring substance p-Mentha-1,8-dien-7-al (also called
“Perilla aldehyde”) has been shown to be genotoxic (damaging to DNA) in a new study on animals, evaluated by EFSA’s
experts. Under EFSA’s process for the safety assessment of
food flavourings, once a substance is characterised as a genotoxin, EFSA concludes on this aspect only without taking into
account consumer exposure.
In 2002, an international evaluation of Perilla aldehyde as a
food flavouring found it to be “no safety concern at current
levels of intake”. In 2008, the European Commission asked
EFSA to re-evaluate this substance as part of the evaluation of
all food flavourings authorised for use in the EU.
2. German Federal Institute for Risk Assessment
(Bundesinstitut für Risikobewertung; BfR) 2.1 Food Safety 2.1.1 Arsenic in Rice and Rice Products
2.1.2 FAQ on Caffeine and Foods Containing Caffeine,
including Energy Drinks
2.1.3 Microplastic Particles in Food 2.2 Vitamins and minerals
2.2.1 Updated FAQ about Folate and Folic Acid
2.3 BfR review of the IARC monograph of glyphosate
brought into the European assessment process 2.4 Development of a method for the chemical characterisation
of flavours and additives in tobacco products 22
22
22
22
22
23
23
23
23
submitted in 2014 is the focus of the current EFSA opinion,
which concludes that Perilla aldehyde induces DNA damage
in the liver. EFSA’s experts noted, however, some weaknesses
in the historical control data (i.e. concerning the test animals
not exposed to the specific substance under examination) of
the laboratory that carried out this test.
Under the EU system devised to evaluate flavourings, Perilla
aldehyde is also a proxy for evaluating nine other structurally
similar chemicals known collectively as “alicyclic aldehydes”.
EFSA’s experts, therefore, indicate there is also a potential safety concern for these other substances unless further evidence
proves otherwise.
Perilla aldehyde occurs naturally in the peel of citrus fruits. It is
produced in limited quantities and added to some baked
foods, puddings, meat products and both alcoholic and nonalcoholic drinks to produce a pungent citrus smell and a woody, spicy, citrus taste.
The flavouring industry first submitted data for this flavouring
substance in 2012 following an EFSA request. EFSA’s experts
EU risk managers will consider how to best use EFSA’s scientithen concluded in 2013 that the substance was potentially
genotoxic and requested an additional study to determine the fic opinion in weighing up possible follow-up measures. By
means of Commission Regulation (EU) 2015/1760 Perilla
potential effects on the liver and stomach. The new study
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18
aldehyde has already been deleted from the Union list of
Regulation (EC) No 1334/2008. Foods to which the flavouring
substance has been added which were lawfully placed on the
market before the date of entry into force of this Regulation
(2 October 2015) may be marketed until their date of minimum durability or use by date.
1.1.2 Acrylamide in food is a public health concern
Following a comprehensive review, EFSA has published its scientific opinion on acrylamide in food. Experts from EFSA’s
Panel on Contaminants in the Food Chain (CONTAM) have
reconfirmed previous evaluations that acrylamide in food
potentially increases the risk of developing cancer for consumers in all age groups. This conclusion has not changed since
the draft opinion was made available for an open public consultation in July 2014.
Evidence from animal studies shows that acrylamide and its
metabolite glycidamide are genotoxic and carcinogenic: they
damage DNA and cause cancer. Evidence from human studies
that dietary exposure to acrylamide causes cancer is currently
limited and inconclusive.
Since acrylamide is present in a wide range of everyday foods,
this health concern applies to all consumers but children are
the most exposed age group on a body weight basis. The
most important food groups contributing to acrylamide exposure are fried potato products, coffee, biscuits, crackers, crisp
bread and soft bread.
Acrylamide is a chemical that naturally forms in starchy food
products during every-day high-temperature cooking (frying,
baking, roasting and also industrial processing, at +120°C and
low moisture). The main chemical process that causes this is
known as the Maillard Reaction; it is the same reaction that
‘browns’ food and affects its taste. Acrylamide forms from
sugars and amino acids (mainly one called asparagine) that
are naturally present in many foods. Acrylamide also has many
non-food industrial uses. It is also present in tobacco smoke.
Following ingestion, acrylamide is absorbed from the gastrointestinal tract, distributed to all organs and extensively metabolised. Glycidamide is one of the main metabolites resulting
from this process and the most likely cause of the gene mutations and tumours seen in animal studies.
Besides cancer, the Panel also considered possible harmful
effects of acrylamide on the nervous system, pre- and postnatal development and male reproduction. These effects were
not considered to be a concern, based on current levels of
dietary exposure.
Although not the focus of EFSA’s risk assessment, the scientific
opinion includes an overview of data and literature summarising how the choice of ingredients, the storage method and
the temperature at which food is cooked can influence the
amount of acrylamide in different food types and therefore
the level of dietary exposure.
An overview of EFSA’s risk assessment is given in the separate
EFSA Fact Sheet Acrylamide in food.
1.1.3 Caffeine: EFSA estimates safe intakes
EFSA has published its Scientific Opinion on the safety of caffeine, in which it estimates acute and daily intakes that raise
no safety concerns for the general healthy population. The
opinion also advises on the consumption of caffeine from all
dietary sources in combination with physical exercise, and on
the possible risks of consuming caffeine together with alcohol,
with other substances found in so-called energy drinks, and
with p-synephrine, a substance increasingly found in food
supplements.
The assessment was finalised following extensive input from
Member States, consumer groups, industry and other interested parties. This included a two-month online consultation
and a stakeholder meeting in Brussels. It is the first time that
the risks from caffeine from all dietary sources have been
assessed at EU level. A number of risk assessments have been
carried out previously by national and other authoritative
bodies around the world, which were thoroughly analysed by
EFSA’s working group.
The European Commission asked EFSA to carry out its assessment
after a number of
Member States raised
concerns about adverse health effects associated with caffeine consumption – particularly cardiovascular disease, problems related to the central nervous system (for example, interrupted
sleep and anxiety), and possible risks to foetal health in pregnant women.
A concise summary of the facts on caffeine can be found in
the EFSA Fact Sheet Caffeine.
1.1.4 Perchlorate in fruit and vegetables opinion
re-published
EFSA has re-published its scientific opinion on the risks to
public health from perchlorate in food, particularly in fruit and
vegetables. Adopted in September 2014, the opinion has
been revised because of a technical error. EFSA’s experts have
re-assessed dietary exposure to perchlorate using corrected
data on perchlorate levels in food and taking into account
more recently available occurrence data.
Perchlorate is a contaminant present in the environment naturally and as a result of human activity. The use of natural fertilisers and perchlorate contaminated irrigation water may lead
to substantial concentrations in leafy vegetables. EFSA’s
experts established a tolerable daily intake (TDI) of 0.3 micrograms per kilogram of body weight per day, based on the
inhibition of thyroid iodine uptake in healthy adults. The TDI is
an estimate of the amount of a substance that people can
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19
consume on a daily basis during their whole life without any
appreciable risk to health.
EFSA estimated chronic and ‘short-term’ exposure to perchlorate. A single exposure to perchlorate at levels found in food
and water is unlikely to cause adverse effects on human
health, including the more vulnerable groups of the population. Overall, chronic dietary exposure to perchlorate is of
potential concern, in particular for high consumers in the
younger age groups of the population with mild to moderate
iodine deficiency. Exposure to perchlorate may be of concern
for infants breast-fed by iodine-deficient mothers. The reassessment of dietary exposure did not affect these overall
conclusions.
1.1.5 Chlorate in food: risks for public health
Long-term exposure to chlorate in food, particularly in drinking water, is a potential health concern for children, especially
those with mild or moderate iodine deficiency. But the total
intake on a single day even at the highest estimated levels is
unlikely to exceed the recommended safe level for consumers
of all ages. These are the main conclusions of EFSA’s scientific
opinion on the chronic and acute public health risks from dietary exposure to chlorate (including drinking water).
would drop only slightly and, consequently, this would not
affect the potential risk. Under the unlikely scenario that chlorate levels in all food and drinking water were equal to 0.7
mg/kg, however, dietary exposure would be substantially above current levels.
There were several limitations in the available data for this
work, at least partly due to the limited timeframe allowed for
the assessment. Consequently, EFSA’s experts concluded that
the impact of these scientific uncertainties on the risk assessment is large.
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.
Chlorate can be present in food from the use of chlorinated
water for food processing and the disinfection of food processing equipment. The most affected food groups are fruit and
vegetables. Frozen varieties often account for the highest
levels of chlorate within each food group. This probably
depends on the amount of chlorate in chlorinated water used
for food processing. Drinking water, however, is the main source of chlorate in the diet, possibly contributing up to 60% of
1.1.6GMO
chronic chlorate exposure for infants.
New guidance for strengthening GM risk assessment
New EFSA guidance identifies data that companies need to
Chronic exposure – over time, exposure to chlorate can inhibit supply when applying for renewed authorisation to import
iodine uptake. EFSA has set a tolerable daily intake (TDI) of 3
genetically modified (GM) plants for food and feed into the
micrograms per kg (µg/kg) of body weight per day for longEuropean Union (EU).
term exposure to chlorate in food. EFSA’s highest estimates of
chronic exposure for infants, toddlers and other children (up
The European Commission grants authorisations to place GM
to 10 years of age) are over the TDI, indicating a concern for all food and feed on the European market for a period of ten
children with mild or moderate iodine deficiency.
years. Companies that want to continue importing GM food
and feed into the EU need to renew the initial authorisation.
Acute exposure – a high intake of chlorate on a single day
could be toxic for humans as it can limit the blood’s ability to
The new guidance ensures a sound scientific basis for the risk
absorb oxygen, leading to kidney failure. EFSA has, therefore,
assessment of GM food and feed in the interest of the Euroalso set a recommended safe intake level for a daily intake
pean consumer. EFSA’s task is to evaluate the validity of previ(called the ‘acute reference dose’) of chlorate of 36 µg/kg of
ous risk assessments of these GM products. It needs to verify if
body weight per day. The highest estimates of acute dietary
any changes, new hazards, modified exposure scenarios or
exposure for all age groups were below this safe intake.
new scientific uncertainties have surfaced. On that basis, EFSA
advises the European Commission and Member States who
In addition, EFSA was asked by the European Commission to
decide whether or not to renew the authorisation.
consider the impact on dietary exposure of applying the WHO
guidance level for chlorate in drinking water of 0.7 milligrams Furthermore EFSA published guidance for clarifying the data
per kilogram (mg/kg) to all foods covered by EU legislation. If
which are needed for the agronomic and phenotypic charac0.7 mg/kg were used as the maximum level in food for asses- terisation of genetically modified (GM) plants. The document
sing dietary exposure to chlorate (i.e. excluding foodstuffs and complements existing guidance on data requirements for the
drinking water containing chlorate above this level), exposures risk assessment of GM plants. It provides applicants seeking
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20
market approval for a GM plant in the European Union with
recommendations on how to generate, analyse and interpret
agronomic and phenotypic data of the GM plant.
balance, cell regulation and signaling, and the mineralisation
of bones and teeth, as well as being a component of cell
structure.
1.1.7AOB
Updated EFSA food classification to support data
collection and aid data providers
EFSA has improved its harmonised food classification and
description system (called ‘FoodEx2’) to further help national
data collection agencies and other scientific bodies provide
comparable scientific data for use in risk assessments. The
advanced features of FoodEx2 have led the Food and Agricultural Organisation (FAO) and World Health Organization
(WHO) to adopt EFSA’s system as the basis for a global system.
For phosphorus the Panel set an AI for adults of 550 mg/day.
For children the range is between 250 and 640 mg/day.
Read more...
The FoodEx2 system classifies and describes food, drink and
food commodities in data collections across different food
safety areas. The system allows harmonised Europe-wide
reporting of data on food consumption and occurrence of
chemical hazards (e.g. contaminants, pesticides) in food. These
data are fundamental to EFSA’s work as they are used to assess
consumer exposure to food-related risks in the European
Union.
For vitamin E as α-tocopherol, the Panel on Dietetic Products,
Nutrition and Allergies (NDA) set adequate intakes (AIs) of 13
mg/day for men and 11 mg/day for women. For infants and
children the AIs range from 5-13 mg/day. Read more…
FoodEx2 is now the standard for the collection and transmission of data from the EU Member States to EFSA. FAO and WHO
have recently decided to work together with EFSA to use the
FoodEX2 as a basis for “a food categorisation system applicable
at global level”. This development is part of the framework for
a pilot Global Individual Food consumption data Tool (FAO/
WHO GIFT) that will facilitate access to data on food availability and produce food-based indicators comparable across the
globe.
This update builds on feedback from use of FoodEx2 since its
introduction in 2011. This update Revision 2 of FoodEx2 replaces ‘Revision 1’ and comes into immediate effect.
1.2
1.2.2 Dietary reference values: Vitamin E and Cobalamin
EFSA’s nutrition experts have set dietary reference values
(DRVs) for vitamin E as α-tocopherol and cobalamin (vitamin
B12). The work is part of the Authority’s updating of nutrient
and energy requirements set by the European Commission in
1993.
For cobalamin, the Panel set AIs of 4 µg/day for adults (18
years and above) and of between 1.5 and 4 µg/day for infants
and children. Read more...
meyer.science provides comprehensive regulatory
and scientific advisory services for national and international food, cosmetic and pharmaceutical companies. meyer.science provides support in all phases of
product development, and in particular in the following areas:

Vitamins and minerals
1.2.1 Dietary Reference Values: Magnesium and
Phosphorus
EFSA has proposed adequate intakes (AIs) for magnesium and
phosphorus as part of its ongoing review of dietary reference
values in the European Union.
Magnesium is a cofactor of more than 300 enzymatic reactions, such as the synthesis of carbohydrates, lipids, nucleic
acids and proteins, and is necessary for specific actions in various organs in the neuromuscular and cardiovascular systems.
EFSA set an AI for magnesium of 350 mg/day for men and 300
mg/day for women. For children the AI ranges from 170 to
300 mg/day, according to age. Read more...
Phosphorus is involved in many physiological processes, such
as the cell’s energy cycle, regulation of the body’s acid–base

labelling advice
clarification of regulatory borderlines
preparation of dossiers and submission of
applications for authorization of health claims,
novel food and food additives
risk assessment (contaminants, pesticide
residues)
communication with competent authorities
organization of training courses (in-house
training)
Furthermore, their service also covers food contact
materials, and consumer products such as toys and
textiles. Additional value to company´s business can
be offered due to our inter-disciplinary support:
comprehensive regulatory and scientific consulting
combined with legal advice from meyer.lawyers offered under one roof.
meyer.science GmbH
Sophienstrasse 5
D - 80333 Munich
www.meyerscience.de
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1.2.3 Dietary Reference Values for Calcium
EFSA has proposed dietary reference values (DRVs) for calcium,
as part of its continuing work on DRVs for European citizens.
Calcium is an integral component of the skeleton; approximately 99 % of total body calcium is found in bones and
teeth, where it has a structural role. The remaining 1 % performs vascular, neuromuscular and endocrine functions in
cells and tissues.
2. German Federal Institute for Risk Assessment
(Bundesinstitut für Risikobewertung; BfR)
2.1
Food Safety
2.1.1 Arsenic in Rice and Rice Products
The level of arsenic in rice depends on several factors, such as
the concentration in the soil and in irrigation water, the type
of rice and also the preparation of the food. If intake is longterm, inorganic arsenic compounds can impair various organs,
The main dietary sources of calcium in European countries dif- even if ingested in comparatively small quantities. The intake
fer, although dairy products are generally the most important of inorganic arsenic with drinking water correlates in epidefood group. Other rich food sources include dark green vege- miological studies among other things with skin diseases and
tables, legumes, nuts, fish with soft bones and calcium-fortian increased risk of contracting certain types of cancer. For
fied foods. Hard water also makes a significant contribution to this reason, international panels classify inorganic arsenic as
calcium intake. Read more...
carcinogenic for humans. The carcinogenic mechanism of
inorganic arsenic has not been fully clarified yet. Thus it has
1.2.4 Dietary Reference Values for Vitamin A
not been possible up to now to derive a safe intake quantity
EFSA has set population reference intakes for vitamin A as part which may not involve an increased risk of cancer. The exisof its review of scientific advice on nutrient intakes.
tence of inorganic arsenic in foods is therefore undesired in all
quantities, although it cannot be completely avoided.
The Panel on Dietetic Products, Nutrition and Allergies (NDA)
set daily population reference intakes (PRIs) for vitamin A of:
After making an assessment based on the Margin of Exposure
concept, the BfR arrives at the conclusion that health impair• 750 μg for men and 650 μg for women. ments concerning the risk of cancer are possible. The levels of
• 250 to 750 μg for infants and children. inorganic arsenic in foods should therefore be reduced to an
• 700 μg for pregnant women, which is higher than the unavoidable minimum (ALARA principle).
adult PRI to allow for needs of the foetus and the
growth of maternal tissues.
The BfR recommends that possibilities to reduce exposure to
inorganic arsenic compounds from rice and rice products be
Analysis of data in EFSA’s Comprehensive Food Consumption
examined. The data show that the levels in several of the rice
Database and Nutrient Composition Database shows that in
products examined are higher than in grains of rice. The reathe EU average vitamin A intake ranges between 409–651 μg/ sons for the higher levels of arsenic compounds in these rice
day for children aged 1 to 3; 607–889 μg/day for children aged products compared to grains of rice should be clarified.
3 to 10; 597–1,078 μg/day for adolescents (10 to 18 years); and Options to minimise the levels of arsenic in these products
816–1,498 μg/day for adults.
should be evaluated. Furthermore, the consumption data on
rice products should be updated so that exposure can be estiVitamin A is a fat soluble vitamin obtained from the diet either mated realistically, especially where small children are
as preformed vitamin A (mainly retinol and retinyl esters) in
concerned.
foods of animal origin, or as provitamin A carotenoids in plantderived foods. Foods rich in vitamin A include meat, butter,
2.1.2 FAQ on Caffeine and Foods Containing Caffeine,
retinol-enriched margarine, dairy products, eggs, and vegetab- including Energy Drinks
les and fruits such as sweet potatoes, carrots, pumpkins, dark
Foods containing caffeine have been consumed by humans
green leafy vegetables, sweet red peppers, mangoes and
for hundreds of years due to their stimulating effect on the
melons. Vitamin A is important for the maintenance of healthy cardiovascular and central nervous system. Energy drinks or
vision, and the growth and integrity of cells in body tissues.
energy shots are drinks which often contain high concentraRead more...
tions of caffeine. They are frequently advertised as having the
ability to enhance the mental alertness and physical performance. The occurrence of possible adverse health effects such
meyer
on
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22
as nervousness or cardiac arrhythmias due to the consumption of products containing caffeine depends on individual sensitivity to caffeine and the extent of consumption of foods of
this kind. The BfR already pointed out possible negative health
effects of the excessive consumption of energy shots and
energy drinks back in 2008 and 2009. The European Food Safety Authority (EFSA) published a scientific opinion on the safety
of caffeine in 2015. The BfR recently published frequently
asked question in connection with foods containing caffeine,
in particular energy drinks.
Folic acid is used in food supplements and for fortification of
foods. Women who want to or might become pregnant and
women in the first trimester of pregnancy are advised to take
folic acid in supplement form, in addition to a high-folate diet,
as this can reduce the risk of a neural tube defect (spina bifida)
in their child. Read more...
2.1.3 Microplastic Particles in Food
The term microplastic is used for small plastic particles of different origins, sizes and chemical composition. The exact sizes of
microplastics have not been uniformly defined in the relevant
literature, they mostly range from 0.001 mm to less than 5
mm. Basically, two types of microplastics are distinguished, primary and secondary microplastic. Primary microplastic is specific produced industrially in the form of plastic-based granulates or pellets. Secondary microplastic occurs through chemical and physical ageing and degradation processes in products such as plastic bags and plastic bottles. As far as can be
ascertained today, secondary microplastic is the main source
of entry into the environment.
The BfR has reviewed the monograph of the International
Agency for Research on Cancer (IARC) on the health assessment of glyphosate and given its evaluation to the Federal
Office of Consumer Protection and Food Safety (BVL) within
the specified timeframe. In the next stage of the process, the
BVL forwarded the German evaluation to the European Food
Safety Authority (EFSA) which will in turn send it to all EU
member states for consultation. By doing so, it will be achievable to make the review of the IARC monograph as part of
the reassessment of glyphosate within the scope of the EU
examination of active substances. The evaluation of the IARC
monograph will be finally discussed and coordinated at a
Pesticide Risk Assessment Unit (PRAS) Meeting of experts at
the EFSA under consideration of all comments from the EU
member states so that the result of the joint consultation can
flow into the final EFSA recommendation to the EU
Commission.
Currently, the BfR does not have any reliable data on the chemical composition, particle size or concentration of microplastic particles in food. Due to a lack of robust data, a health risk
assessment of the consumption of food contaminated with
microplastic particles is presently not possible. The BfR has
requested the EFSA for a scientific opinion on the occurrence
of microplastic and nanoplastic particles in food, especially in
seafood.
2.3 BfR review of the IARC monograph of
glyphosate brought into the European
assessment process
2.4 Development of a method for the chemical
characterisation of flavours and additives in
tobacco products
The new Tobacco Product Directive 2014/40/EU must be
implemented as national law by the EU member states by
May 2016. For cigarettes and hand-rolling tobacco, the directi2.2.1 Updated FAQ about Folate and Folic Acid
ve will, among other things, introduce a ban on characteristic
The term “folate” denotes a water-soluble vitamin that is essen- aromas such as menthol, cloves, vanilla and various fruit flatial for human health. The vitamin plays a role in many metavours. However, adding scents and flavours generally remains
bolic processes in the human body and must therefore be
permitted, as long as the smoker cannot detect a so-called
supplied in adequate amounts through the food we eat. Fola- “characteristic flavour”. The question whether added flavours
te compounds occur naturally in foods of plant and animal
merely modify the actual tobacco scent or whether they are
origin, such as green cabbage, lamb’s lettuce or eggs. The syn- perceived as a characteristic product feature poses new chalthetically produced form of folate is called “folic acid”.
lenges for risk assessment and product monitoring. Using the
example of strawberry flavour, the Federal Institute for Risk
Assessment (BfR) has recently conducted a study to investigate to what extent chemical analytical procedures can be used
to identify characteristic aromas, possibly as a supplement for
sensory test methods.
2.2
Vitamins and minerals
Further information is available in the article “Toward the stereochemical identification of prohibited characterizing flavors
in tobacco products: the case of strawberry flavour” and the
guest editorial “European Tabacco Product Directive: How to
address characterizing flavor as a matter of attractiveness” written by BfR scientists in the scientific journal “Archives of Toxicology” (July 2015).
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23
New Law –
in headwords & details
Alfred Hagen Meyer I meyer.rechtsanwälte
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
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) 2015/537 of 31 March 2015
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 cochineal, carminic acid, carmines (E 120)
in dietary foods for special medical purposes (OJ L 88,
1.4.2015, p. 1–3)
- Commission Regulation (EU) 2015/639 of 23 April 2015
amending Annex III to Regulation (EC) No 1333/2008 of the
silicon dioxide (E 551) in polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E 1209) (OJ L 106, 24.4.2015, p. 16–17)
- COMMISSION REGULATION (EU) 2015/647 of 24 April 2015
amending and correcting Annexes II and III to Regulation (EC)
No 1333/2008 of the European Parliament and of the Council
as regards the use of certain food additives (OJ L 107,
25.4.2015, S. 1–14)
European Parliament and of the Council and the Annex to
Commission Regulation (EU) No 231/2012 as regards the use
of L-leucine as a carrier for table-top sweeteners in tablets (OJ
L 107, 25.4.2015, p. 17–20)
- Commission Regulation (EU) 2015/1362 of 6 August 2015
silicon dioxide (E 551) in extracts of rosemary (E 392) (OJ L
210, 7.8.2015, S. 22–23
- Commission Regulation (EU) 2015/1378 of 11 August 2015
riboflavins (E 101) and carotenes (E 160a) in dried potato granules and flakes (OJ L 213, 12.8.2015, S. 1–3)
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24
Nr.
Legal Norm
Amendment
600
2008 on food additives (OJ L 354, 31.12.2008)
- Commission Regulation (EU) 2015/1739 of 28 September
2015 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
use of the iron tartrate as an anti-caking agent in salt and its
substitutes (OJ L 253, 30.9.2015, S. 3–6)
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)
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 polyvinyl alcohol (E 1203) (ABl. L 76, 20.3.2015, S. 42–43)
2015 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 Ethyl
lauroyl arginate (E 243) (OJ L 252, 29.9.2015, S. 12–13)
2015 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
use of the iron tartrate as an anti-caking agent in salt and its
substitutes (OJ L 253, 30.9.2015, S. 3–6)
800
2008 on flavourings and certain food ingredients with flavouring properties for use in and
on foods (OJ L 354, 31.12.2008, p. 34–50)
amending Annex I to Regulation (EC) No 1334/2008 of the
European Parliament and of the Council as regards removal
from the Union list of the flavouring substance of N-Ethyl
(2E,6Z)-nonadienamide (OJ L 107, 25.4.2015, p. 15–16)
- Commission Regulation (EU) 2015/1102 of 8 July 2015
amending Annex I to Regulation (EC) No 1334/2008 of the
European Parliament and of the Council as regards removal
from the Union list of certain flavouring substances (OJ L 181,
9.7.2015, S. 54–56)
Contaminants, Residues
1205
Commission Regulation (EC) No 1881/2006 of
19 December 2006 setting maximum levels for
certain contaminants in foodstuffs (Official Journal 364/5, 20.12.2006)
- Commission Regulation (EU) 2015/1005 of 25 June 2015
amending Regulation (EC) No 1881/2006 as regards maximum levels of lead in certain foodstuffs (OJ L 161/9, 26 June
2015)
amending Regulation (EC) No 1881/2006 as regards maximum levels of inorganic arsenic in foodstuffs (OJ L 161/9, 26
June 2015)
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25
Nr.
Legal Norm
Amendment
1205
Commission Regulation (EC) No 1881/2006 of
19 December 2006 setting maximum levels for
certain contaminants in foodstuffs (Official Journal 364/5, 20.12.2006)
amending Regulation (EC) No 1881/2006 as regards the maximum level of Ochratoxin A in Capsicum spp. spices (OJ L 185,
14.7.2015, S. 11–12)
1220
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)
- Corrigendum to Commission Regulation (EU) No
668/2013 of 12 July 2013 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 2,4-DB,
dimethomorph, indoxacarb, and pyraclostrobin in or on certain products (ABl. L 64 vom 7.3.2015, S. 46–46)
- Commission Regulation (EU) 2015/399 of 25 February
2015 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 1,4-dimethylnaphthalene,
benfuracarb, carbofuran, carbosulfan, ethephon, fenamidone,
fenvalerate, fenhexamid, furathiocarb, imazapyr, malathion,
picoxystrobin, spirotetramat, tepraloxydim and trifloxystrobin
in or on certain products (L 71, 14 March 2015)
2015 amending Annexes II, III and V to Regulation (EC) No
regards maximum residue levels for bone oil, carbon monoxide, cyprodinil, dodemorph, iprodione, metaldehyde, metazachlor, paraffin oil (CAS 64742-54-7), petroleum oils (CAS
92062-35-6) and propargite in or on certain products (L 71, 14
March 2015)
2015 amending Annexes II and III to Regulation (EC) No
regards maximum residue levels for acetamiprid, chromafenozide, cyazofamid, dicamba, difenoconazole, fenpyrazamine,
fluazinam, formetanate, nicotine, penconazole, pymetrozine,
pyraclostrobin, tau-fluvalinate and tebuconazole in or on certain products (L 71, 14 March 2015)
amending Annexes II, III and V to Regulation (EC) No
regards maximum residue levels for 1,3-dichloropropene,
bifenox, dimethenamid-P, prohexadione, tolylfluanid and trifluralin in or on certain products (OJ L 92, 8.4.2015, p. 20–85)
- Corrigendum to Commission Regulation (EU) 2015/552 of
7 April 2015 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 1,3-dichloropropene,
bifenox, dimethenamid-P, prohexadione, tolylfluanid and trifluralin in or on certain products (OJ L 94, 10.4.2015, p. 8–8)
© PHE Health Matters smoking
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26
Nr.
Legal Norm
Amendment
1220
regards maximum residue levels for 2-naphthyloxyacetic acid,
acetochlor, chloropicrin, diflufenican, flurprimidol, flutolanil
and spinosad in or on certain products (OJ L 100, 17.4.2015, p.
10–59)
- Commission Regulation (EU) 2015/845 of 27 May 2015
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 azoxystrobin, chlorantraniliprole,
cyantraniliprole, dicamba, difenoconazole, fenpyroximate, fludioxonil, glufosinate-ammonium, imazapic, imazapyr, indoxacarb, isoxaflutole, mandipropamid, penthiopyrad, propiconazole, pyrimethanil, spirotetramat and trinexapac in or on certain products (OJ. L 138, 4.6.2015, S. 1–69)
maximum residue levels for acetamiprid, ametoctradin, amisulbrom, bupirimate, clofentezine, ethephon, ethirimol, fluopicolide, imazapic, propamocarb, pyraclostrobin and tau-fluvalinate in or on certain products (OJ L 140, .56.2015, S. 1–49)
regards maximum residue levels for 2,4,5-T, barban, binapacryl, bromophos-ethyl, camphechlor (toxaphene), chlorbufam,
chloroxuron, chlozolinate, DNOC, di-allate, dinoseb, dinoterb,
dioxathion, ethylene oxide, fentin acetate, fentin hydroxide,
flucycloxuron, flucythrinate, formothion, mecarbam, methacrifos, monolinuron, phenothrin, propham, pyrazophos, quinalphos, resmethrin, tecnazene and vinclozolin in or on certain
products (OJ L 145, 10.6.2015, S. 1–71)
amending Annex IV to Regulation (EC) No 396/2005 of the
European Parliament and of the Council as regards maximum
residue levels for Trichoderma polysporum strain IMI 206039,
Trichoderma asperellum (formerly T. harzianum) strains
ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strains IMI 206040 and T11, Trichoderma harzianum
strains T-22 and ITEM 908, Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma asperellum (strain T34), Trichoderma atroviride strain I-1237, geraniol, thymol, sucrose, ferric
sulphate (iron (III) sulphate), ferrous sulphate (iron (II) sulphate) and folic acid in or on certain products (OJ L
147,12.6.2015, S. 3–7)
© Stiftung Warentest Speiseöle
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Nr.
Legal Norm
Amendment
1220
regards maximum residue levels for azoxystrobin, dimoxystrobin, fluroxypyr, methoxyfenozide, metrafenone, oxadiargyl
and tribenuron in or on certain products (OJ L 167, 1.7.2015,
p. 10–56)
26 May 2015 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 2,4,5-T, barban,
binapacryl, bromophos-ethyl, camphechlor (toxaphene),
chlorbufam, chloroxuron, chlozolinate, DNOC, di-allate, dinoseb, dinoterb, dioxathion, ethylene oxide, fentin acetate, fentin hydroxide, flucycloxuron, flucythrinate, formothion, mecarbam, methacrifos, monolinuron, phenothrin, propham, pyrazophos, quinalphos, resmethrin, tecnazene and vinclozolin in
or on certain products (OJ L 174, 3.7.2015, p. 43–43)
maximum residue levels for difenoconazole, fluopicolide, fluopyram, isopyrazam and pendimethalin in or on certain products (OJ L 181, 9.7.2015, S. 27–53)
maximum residue levels for amidosulfuron, fenhexamid, kresoxim-methyl, thiacloprid and trifloxystrobin in or on certain
products (OJ L 195, 23.7.2015, S. 1–36)
13 April 2015 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 2-naphthyloxyacetic acid, acetochlor, chloropicrin, diflufenican, flurprimidol, flutolanil and spinosad in or on certain products (OJ L
234, 8.9.2015, S. 27–27)
Pharmacologically Active Substances
1500
Commission Regulation (EU) No 37/2010 of
22 December 2009 on pharmacologically active
substances and their classification regarding
maximum residue limits in foodstuffs of animal
origin (L 15/1, 20.1.2010)
- Commission Implementing Regulation (EU) 2015/394 of
10 March 2015 amending the Annex to Regulation (EU) No
37/2010 as regards the substance ‘tulathromycin’ (ABl. L 66
vom 11.3.2015, S. 1–3)
17 March 2015 amending Regulation (EU) No 37/2010 as
regards the substance ‘barium selenate’ (ABl. L 74 vom
18.3.2015, S. 18–20)
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Nr.
Legal Norm
Amendment
1500
Commission Regulation (EU) No 37/2010 of
22 December 2009 on pharmacologically active
substances and their classification regarding
maximum residue limits in foodstuffs of animal
origin (L 15/1, 20.1.2010)
3 September 2015 amending Regulation (EU) No 37/2010 as
regards the substance ‘virginiamycin’ (OJ 231/7, 4 September
2015)
3 September 2015 amending Regulation (EU) No 37/2010 as
regards the substance ‘tylvalosin’ (OJ 231/10, 4 September
2015)
REACH, Biocidal Products
2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals
(REACH), establishing a European Chemicals
Agency (Official Journal L 396/1, 30.12.2006)
amending Annex XVII to Regulation (EC) No 1907/2006 of the
European Parliament and of the Council on the Registration,
Evaluation, Authorisation and Restriction of Chemicals
(REACH) as regards polycyclic aromatic hydrocarbons and
phthalates (ABl. L 58 vom 3.3.2015, S. 43–45)
amending Annex XVII to Regulation (EC) No 1907/2006 of the
European Parliament and of the Council on the Registration,
Evaluation, Authorisation and Restriction of Chemicals
(‘REACH’) as regards lead and its compounds (OJ L 104,
23.4.2015, p. 2–5)
amending Regulation (EC) No 1907/2006 of the European
Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) (ABl. L
132, 29.5.2015, S. 8–31)
Novel Food
online
Directive 2001/18/EC
- Directive (EU) 2015/412 of the European Parliament and of
the Council of 11 March 2015 amending Directive 2001/18/
EC as regards the possibility for the Member States to restrict
or prohibit the cultivation of genetically modified organisms
(GMOs) in their territory (ABl. L 68, 13.3.2015, S. 1–8)
Enriched food and Food Supplements
2400
Regulation (EC) No 1925/2006
European Parliament and of the Council as regards Ephedra
species and Yohimbe ( Pausinystalia yohimbe (K. Schum)
Pierre ex Beille) (ABl. L 67, 12.3.2015, S. 4–5)
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Nr.
Legal Norm
Amendment
2500
Directive 2002/46/EC
amending Directive 2002/46/EC of the European Parliament
and of the Council as regards (6 S )-5-methyltetrahydrofolic
acid, glucosamine salt used in the manufacture of food supplements (ABl. L 68, 13.3.2015, S. 26–27)
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)
17 June 2015 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 151, 18.6.2015, S. 1–19)
- Corrigendum to Commission Implementing Regulation
(EU) 2015/131 of 23 January 2015 amending 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 241, 17.9.2015, S. 51–51)
Food Monitoring
8540
Regulation (EC) No 669/2009 implementing
Parliament and of the Council as regards the
increased level of official controls on imports of
certain feed and food of non-animal origin
27 March 2015 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 (ABl. L 84, 28.3.2015, S. 23–29)
24 September 2015 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 249, 25.9.2015, S. 7–13
TSE
9420
Parliament and of the Council of 22 May 2001
laying down rules for the prevention, control
and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p.
1–40)
amending the definition of specified risk material set out in
Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 116, 7.5.2015, p. 1–2)
amending Annex V to Regulation (EC) No 999/2001 of the
European Parliament and of the Council laying down rules for
the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 188, 16.7.2015, S. 3–5)
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meyer@meyerlegal.de
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to Erin M. Covert, J.D.,
erin@ag-hag.org
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In a decade of information overload, this newsletter clarifies foodrelated topics in simple terms and filters the flood of legal and
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Authors of this issue
Magnus Friberg
Food innovation – too much debate, too few facts?
Alfred Hagen Meyer & Anna Märtlbauer
Compliance in the food industry?
Anne-Marie Taylor
CJEU Ruling On Health Claims
Dominic Watkins and Anne-Marie Taylor
Composition in focus in the UK as the health agenda is a central focus
Dominic Watkins
In brief
Kayra Üçer & Candan Çırnaz
Turkey – Recent Developments in Relation to the Use of Genetically Modified
Organisms
Eva Maria Kostenzer
Recent decisions of the Austrian regional administrative courts relating
to food law matters
Jörg-Michael Scheil
Update on Food Law in China: New Food Safety Law 2015
Uta Verbeek, Kerstin Baumgärtner & Brigitte Ruisinger
Regulatory News
Alfred Hagen Meyer
New Law
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