February 2021 - American Herbal Products Association
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IADSA NEWSFLASH | February 2021
2020
February 2021
patients having autoimmune disease Claims - Nutrient Supplement (2020).
(like rheumatoid) or hyperthyroidism Both regulations will come into force
should take the product with caution. on 1 March 2021, replacing the Health
Regulatory news Function: Sleep improvement
Fish oil Daily intake: No more than
Food Raw Materials Directory (1st
Batch) and the Health Function
Catalogue (1st batch) released in 2016.
4.0g (among them, the usage amount
The new versions also provide new
of EPA+DHA should be no less than interpretation claims. It is clarified
1.0g). Suitable group: People with high that it would be possible to include
blood lipids. Unsuitable groups: one or more sentences of the
Children, pregnant women, lactating interpretation claims on a label.
women; those with bleeding tendency However, words cannot be deleted,
and patients with bleeding diseases; added or modified.
those with hepatic insufficiency; those
China who are allergic to marine products.
Function: Assist to reduce blood lipids
Addressing variation
New functional ingredients
Reishi shell-broken spore powder
Daily intake 1-4g Suitable group: Those The China State Administration for
Coenzyme Q10, reishi shell-broken with weakened immune systems Market Regulation (SAMR) has recently
spore powder, spirulina, fish oil and Unsuitable groups: Children, pregnant issued a notification on management of
melatonin are now officially women, lactating women Function: health food registration for variations
considered as functional ingredients Enhance immunity made to existing applications. The
with their inclusion into the health variation can affect the product name,
food raw material positive list. In a Spirulina Daily intake 3-4g Suitable health functions, or change of label
communication from SAMR on 3 group: Those with weakened immune contents (limited to deleting the
December, it has also been clarified systems. Unsuitable groups: Children, preface, removing health functions,
that ingredients and related functions pregnant women, lactating women and reducing the scope of the “suitable
can only apply to the production of those with allergic constitution. for” or expand the scope of
health food instead of ordinary food. Function: Enhance immunity. Also note “unsuitable for”, standardizing the
that beta carotene has also been expression of specifications or
Coenzyme Q10 Daily intake 30-50mg added to the list of nutrients for health
Suitable group: Adults Unsuitable cautions, and specifying edible
food filing as a source suitable for method). According to this
groups: Children, pregnant women,
lactating women, those with allergies, adults. notification, the changes made should
people taking pharmaceutical drugs not affect health food quality and
should consult the doctor before safety, or invalidate the registration.
Update!
consuming the product Function:
Enhance immunity; antioxidation Series of changes
The State Administration for Market
Regulation (SAMR), the National Health The China State Administration for
Melatonin Daily intake 1-3mg Suitable Commission ("NHC") and National Market Regulation (SAMR) has recently
group: Adults Unsuitable groups: Administration of Traditional Chinese released a series of draft regulations
Children, pregnant women, lactating Medicine have released the Health related to health food functions for
women, people who work on driving, Food Raw Material Directory - Nutrient public consultation, namely:
mechanical operation and dangerous Supplement (2020) and Health
operation cannot consume this product Function Catalogue Allowed for Health
before or during the operation, and • Health Function Catalogue
Allowed for Health Food
Claims Non-nutrient
Supplement (2020 Draft)
• Interpretation of Health
Functions (2020 Draft)
• Evaluation Guideline for
Health Food Functions (2020
Draft)IADSA NEWSFLASH | February 2021
• Ethical Review Guideline for manufactured in Korea with imported European Union
Health Food Human functional ingredients, HACCP
Consumption Trial (2020 accreditation would be sufficient.
New look at CBD
Draft)
Following a recent EU Court judgment
Among the changes introduced: Suspension of foods produced by (Case C-663/18) reporting that a
ruminant and its by-products from Member State may not prohibit the
36 countries marketing of cannabidiol (CBD)
• Three functions (Promoting
lactation, Improving growth, lawfully produced in another Member
Improving skin lipid) have now The MFDS, the Korean Ministry of Food State when it is extracted from the
been removed, reducing the and Drug Safety, has recently banned Cannabis sativa plant in its entirety
list of permitted functions the import of foods produced by and not solely from its fibre and seeds,
from 27 to 24. ruminants and its by-products from 36 the European Commission has officially
countries/regions. Under Korean law, changed its position relating to the
• 6 functions have also been
MFDS can prohibit the import of foods status of CBD extracts. The
reworded (e.g. Aiding blood
that contain risk materials or are Commission now considers that CBD
lipid reduction replaced by
manufactured in a harmful extracted from hemp is not a drug and
Help maintain blood lipid
environment. can be eligible for use in food and food
health (cholesterol/
supplements. All CBD extracts remain
triglyceride). The banned materials/foods are: Food novel, requiring the submission and
• It is understood that and food additives using ruminants and approval of a dossier before use. The
additional language that may their by-products as raw materials Commission had received about 60
now be used to further (milk, dairy products, and collagen applications that were put on hold and
explain the function to casing excluded) with the exception of will now proceed with checking their
consumers. foods and products containing: validity. If valid, they will send them
to EFSA for the risk assessment.
On the requirements of heath food Parallel to this, the UN Commission on
function evaluation, more information • Processed beef tallow Narcotic drugs (CND) has voted to
about the tested samples would be products: The contains of reclassify cannabis out of the most
required. This also includes an analysis insoluble impurities in dangerous category of drugs by
report of potentially harmful products: less than 0.15% removing the substance from Schedule
substances for the tested sample. (certificate issued by the IV of the 1961 Single Convention on
exporting country's Narcotic Drugs.
government is required)
The Ethical Review Guideline for • Gelatin, Collagen: Made
Health Food Human Consumption Trial from raw skin or leather Overruling national limits for
(draft) is a new Regulation. It is (certificate issued by the selenium
understood that institutions conducting exporting country's
human trials should establish an government is required)
ethical review committee, made up of • Calcium Phosphate Dibasic:
The EU has recently extended the use
professionals having multiple academic Containing no protein or fats
of the novel food selenium-containing
backgrounds. (certificate issued by the
yeast (Yarrowia lipolytica) biomass in
exporting country's
food supplements under the following
government is required)
conditions: Food supplements,
Korea excluding food supplements for infants
and children under 4 years of age 50
This prohibition applies to Austria, mg/day for children from 4 to 6 years
Belgium France, Germany, Italy, of age, resulting in 10 µg of selenium
General foods can now carry claims Netherlands, Luxembourg, Ireland, per day 100 mg/day for children from
Denmark, Greece, Spain, Portugal, 7 to 10 years of age, resulting in 20 µg
General food can now bear "function Sweden, Finland, Albania, Bosnia and
claims" which were so far only of selenium per day 500 mg/day for
Herzegovina, Bulgaria, Croatia, Czech adolescents from 11 to 17 years of age,
permitted for health functional Republic, Hungary, Liechtenstein,
food.The Ministry of Food and Drug resulting in 100 µg of selenium per day
Macedonia, Norway, Poland, Romania, 800 mg/day for adults, resulting in 160
Safety (MFDS) has recently clarified in Slovakia, Slovenian, Swiss, Serbia,
a Q&A that the use of such claims on µg of selenium per day.
Montenegro, Japan, Israel, Canada,
general food would be permitted if the United States of America, Brazil,
functional ingredient amount exceeds United Kingdom.
30% of the recommended daily intake Some Member States were however
set in Health Functional Food Code. against this measure. Belgium
Currently 29 claims have been indicated that the decision would
approved for use. These include overrule national limits applied in
Ginseng, Chlorella. Spirulina. Propolis some Member States. The Netherlands
extract, EPA, DHA oil, Probiotics. For considered the novel food to be a new
domestic food products, the functional source of selenium as this selenium-
ingredients should be provided by containing yeast biomass will be used
factories in compliance with Health to supplement the dietary intake of
Functional Food Good Manufacturing selenium. The Netherlands suggested
Practice (GMP). However it is to wait for EFSA’s result of the re-
understood that if products are evaluation of the safe upper level thatIADSA NEWSFLASH | February 2021
has been requested by the European France Germany
Commission based on newly emerging
data. Similar concerns were raised for
a novel vitamin D2 mushroom powder Extension of TiO2 ban Stoffliste v2 published
to be used as a new source of
ergocalciferol. The Commission France has extended its national ban The new working Group Bund-Länder-
decision on this novel food could be of the use of the additive titanium Arbeitsgemeinschaft Stoffliste (AG
reviewed when the EFSA option will be dioxide (E171) in foods and Stoffliste) has recently published its
available in July 2021. supplements for another year. No revised list of Plants (Pflanzen)
decision has been taken yet at the EU developed 6 years ago. The new
level. The final EFSA opinion on the version that was open to public
Vegetable carbon: Call for particle safety of E171, based on further consultation in September has been
sizes data & limits for PAHs studies that have been carried out, is developed by representatives of
foreseen by end March 2021. various authorities [the German
The European Commission has federal Authorities (BVL, BfR, BfArM),
published a new call for data regarding the authorities of the German Länder,
the re-evaluation of vegetable carbon Vitamin D: Take medicines not the Swiss Federal Office for Food
(E 153) authorised in supplements at supplements Safety and Veterinary Affairs FSVO, the
Quantum satis. This request includes Austrian agency AGES], as well as
information on particle size and experts in the respective fields not
The French Agency for Food,
particle size distribution for the food under any authority.
Environmental and Occupational
additive, and data on the lowest Health & Safety (ANSES) has recently
technologically achievable levels for 16 published an article recommending the
priority PAHs. Deadline: 14 August use of vitamin D medicines rather than Over 100 monographs and more than
2021 food supplements to prevent the risk 250 plants have been added. In
of overdose in children. addition, a “list of mushrooms” has
α-Lipoic Acid at risk been created. The lists are not legally
binding and do not claim to be
According to the European Food Safety complete. The lists will be updated
According to the Agency, cases of
Authority (EFSA), the consumption of periodically to take into account new
vitamin D overdose have recently been
Alpha Lipoid Acid added to foods, scientific knowledge and market
reported in young children following
including food supplements, is likely to developments.
the use of food supplements. In
lead to an increased risk of developing response to this, ANSES, the French
Insulin Autoimmune Syndrome (IAS) in The lists also serve as a guide in
Health Products Safety Agency (ANSM),
individuals with certain genetic Austria and Switzerland for botanicals
paediatric scientific societies, the
polymorphisms. and mushrooms used as food or food
National College of Midwives and
ingredients.
French poison control centres
are alerting healthcare
Based on the limited data available professionals and parents to the risk of Status of highly bioavailable
and the low prevalence of IAS in overdose associated with giving curcumin
Europe, it was also reported that the vitamin D supplements to children,
risk associated with the development especially infants (link) To prevent this A recent publication of a German Joint
of IAS following consumption of risk, they are asking healthcare Expert Commission has examined how
Alpha Lipoid Acid cannot be professionals and parents to: products containing curcumin with
quantified precisely neither for the improved bioavailability and placed on
general population overall nor for sub- the market as food supplements are to
groups or individuals with genetic • Opt for medicines rather than be classified. While the Joint Expert
susceptibility. food supplements; Commission reported that there was no
• Check the doses administered basis for classifying such products as
functional medicines or traditional
(verify the amount of vitamin D
Such conclusions could lead the per drop); herbal medicinal products, no food
European Commission to impose preparations containing curcumin with
• Avoid combining different
restrictive measures or even a improved bioavailability had been
products containing vitamin D.
prohibition. consumed to any significant extent
within the European Union before 15
May 1997. It was reported that no
ANSES also note that some of the application for approval as a novel
The publication of this scientific potential risk issues relating to food food has been submitted. The Joint
opinion is based on a request of the supplements are linked sometimes to Expert Commission concluded that the
European Commission to initiate the very high (up to 10,000 IU) vitamin D evaluation of the safety of curcumin-
procedure under Article 8 of concentration per drop, the presence containing products with improved
Regulation (EC) No 1925/2006 for the in the food supplement of other bioavailability should therefore be
intake of alpha-lipoic acid in food vitamins (example: vitamin K, for recommended in each individual case
supplements because of the potential which there is no recommendation for due to the heterogeneity of the
risk to health associated with the daily administration to children) or specific manufacturing processes
intake of this substance raised by the high dose calcium (increased risk of
Danish National Food Institute (DTU) renal damage such as lithiasis /
and the Belgian Superior Health nephrocalcinosis).
Council. Norway
Focus on MSM and melatoninIADSA NEWSFLASH | February 2021
The register of authorised claims Due to continuing inflation, Argentina
The Norwegian Food Safety Authority has updated its fees to register food
https://www.gov.uk/government/pub supplements from $11.120,00
(Mattilsynet) has requested its
lications/great-britain-nutrition-and-
Scientific Committee for Food and Argentinean Pesos to $16.240,00. The
health-claims-nhc-register Provision 705/2021 was published on
Environment (VKM) to investigate a
potential health risk associated with a For applications of new health claims 22nd January 2021 which modifies
daily intake of food supplements administrative fees for the National
containing methylsulfonylmethane https://www.gov.uk/government/grou Administration of Medicines, Foods and
(MSM) at a dose of 3 g/day and those ps/uk-nutrition-and-health-claims- Medical Devices (ANMAT) and the
containing melatonin at a dose up to 1 committee#making-an-application-for- National Institute of Foods.
mg/day. VKM was also asked to authorisation-of-a-health-claim
consider how long a food supplement
with 1 mg of melatonin can be taken Enzymes & Processing aids
daily without causing negative health
effects. The conclusion of these risk
Argentina has recently revised its list
assessments must be completed by 12
of enzymes. The revised list contains
May 2021.
108 enzymes for use as processing aids
in food products, including food
supplements, and their conditions of
United Kingdom use. Although the previous list
Argentina contained 106 enzymes, some enzymes
Post Brexit: Not much change have been removed and are not
Revision of FS regulation allowed, and some others have been
Overall, the rules applying to food added. This Resolution has been
supplements remain mostly The National Food Institute (INAL) has developed by the working group on
unchanged, but with national considered it necessary to update enzymes from the National Commission
procedures instead of EU ones. The Article 1381 of the Argentine Food of Foods. The new list is valid from 29
most relevant links have recently Code (CAA) that defines dietary January 2021.
updated by the UK Department of supplements. The new Resolution
Health: published at the end of December
establishes, in addition to the Brazil
definition and particular labelling
Food Supplements Guidance requirements, the requirements that
supplements must meet in terms of
Guidance for food additives
documents
composition. Different regulations such
https://www.gov.uk/government/pub as those of the United States, The sanitary authority ANVISA has
lications/food-supplements-guidance- European Union, Canada, Brazil, Chile, issued the second edition of the Q&A
and-faqs Australia and New Zealand, as well as document on food additives and
https://www.gov.uk/government/publ the recommendations of the Codex processing aids, aiming to clarify
ications/food-supplements-guidance- Alimentarius, were considered. common questions about the
and-faqs/guidance-notes-on- regulation. This includes 70 questions
legislation-implementing-directive- and answers with updated guidance on
200246ec-on-food-supplements the applicable regulation for food
Main changes include: The increase of
additives and processing aids, including
the minimum level for vitamins and
clarification on how to declare food
minerals, from 20% to 30% of the
Scientific applications concerning the additives on labels, the use of
recommended daily intake. The
safety and bioavailability of an botanical species as flavourings, the
Tolerable Upper Intake Levels were
individual substance for consideration safety assessment of food additives,
updated for the following vitamins and
for use in the UK market must until and information on use of the INS
minerals: vitamins A, C, D, E, K,
further notice continue to be number.
thiamin, B6, iron, magnesium and
completed in line with administrative iodine. A maximum level has now been
guidance produced by the European established for boron. It is specified Correcting errors
Commission. Submission should be by that Tolerable Upper Intake Levels
email to: (UL) are established as the maximum In December, an amendment of
nutritionlegislation@dh.gsi.gov.uk safe daily intake for vitamins and Administrative Order 76/2020 was
Nutrition and health claims minerals for dietary supplements. The published which lists the permitted
establishment of limits for amino acids ingredients in food supplements, their
and other nitrogenous substances, respective maximum limits, and the
Guidance document components of the products. The list list of claims, in order to amend
https://www.gov.uk/government/publ of permitted botanicals has been Annexes II, IV and V, where some
ications/nutrition-and-health-claims- reduced from 35 to 27 species. information were incorrect: - Annex II
guidance-to-compliance-with- Requirements for the use of probiotics relating to the permitted ingredients in
have also been included. Enforcement food supplements intended for infant
regulation-ec-1924-2006-on-nutrition-
and-health-claims-made-on- date: 30 December 2020. Companies and young children, where proteins
will have a period to adapt until 30 were missing from the list. - Annex IV
foods/nutrition-and-health-claims-
guidance-to-compliance-with- December 2021. relating to the maximum limits for
bioactive substances, enzymes and
regulation-ec-19242006
probiotics, for each age group, where
Fees for market access a footnote for folic acid has been
added - Annex V relating to the list ofIADSA NEWSFLASH | February 2021
permitted claims, where some wording documents must be submitted supplements and medications may not
has been changed for the permitted in Spanish. be advertised during children’s
claim for Bifidobacterium animalis • Maximum limits of vitamins programmes, including movies aimed
subsp. lactis BB12 (DSM 15954) and minerals are established. at children.
• There is no positive list of
Colombia ingredients, although the Russia
definition foresees vitamins,
Registration fee up minerals, amino acids, Distribution channel restrictions
carbohydrates, proteins, fats, lifted
combinations of substances
In January Resolution 2020046413 was with extracts from plant or
published which updates Resolution Following the approval of the new
animal origin and enzymes rules of goods sales and revocation of
2020027137 which establishes INVIMA’s (except for hormones)
fees, including fees for the registration sanitary norms and rules of production
of food supplements. The new fees
• Labelling requirements and sales of food supplements
have been updated considering the including warning statements (Government Decree N2463 of 31
minimum wage and the current ‘Unit December 2020), all restrictions for
of Tax Value’. The new fees are the retail sales of food supplements are
following: lifted from 1 January 2021. In
particular, the Decree allows E-
commerce trade of dietary
supplements, as well as lifts
• Food supplements in solids
restrictions for retail sales of food
forms: the fee has been
supplements only in pharmacies,
increased from 4,554,638 to
dedicated stores selling preventive and
4,997,071 Colombian Pesos Belarus medical nutrition products, and
• Food supplements in liquid department stores.
form: the fee has been
Dietary supplements & medicines
increased from 4,333,808 to
4,754,533 Colombian Pesos can no longer have identical trade
• Food supplements in semi- names Ukraine
solid form: the fee has been
increased from 4,361,411 to The Belarusian Health Ministry’s Language law comes into force
4,785,032 Colombian Pesos Resolution 78 on criteria for trade
names of medicines of 24 September 16 January 2021 marked the
2020 came into force in November enactment of Article 30 of Ukrainian
2020. Importantly, one of the criteria Law 2704-VIII on facilitating the use of
The new fees are already in force.
bans the use of names fully replicating Ukrainian as the official language for
the names of dietary supplements as consumer services. All market
Nicaragua trade names of medicines. operators are obligated to service
customers and provide information
First legal framework Separate shelves about products and services in
Ukrainian. The requirement is also
Nicaragua has issued its first regulation valid for online information about
The Health Ministry has
for food supplements. products.
ruled medicines and dietary
supplements should be displayed on
In short : As per the law, information about
separate shop shelves. The Belarusian
products and services may be included
national internet portal published the
in other languages.
• The enforcement authority Health Ministry’s Resolution 86 on
will be the Department of amending the Health Ministry’s
Natural Artisan Products and Resolution 120 of 27 December 2006 of Uzbekistan
Nutritional Supplements, 23 November 2020. It states that
which will be linked to the medicines in a pharmacy must be Draft regulation covering
Ministry of Health displayed separately from other supplements
• The import of supplements products, including dietary
registered with the supplements. Dietary supplements
Uzbekistan’s Academy of Sciences has
Department of Natural Artisan must be marked appropriately as a
proposed a draft resolution on safety
Products and Nutritional product category on the dedicated
of food additives, flavouring agents,
Supplements will be shelf.
dietary supplements and processing
authorized by the Department aids. The draft document introduces
of Pharmacy of the Ministry of Change of rules for supplement requirements for their manufacture,
Health adverts storage, sale, disposal and labelling.
• Registration must be issued The document has a number of
within 60 working days. Part Following a new law published in appendices which contain detailed
of the documentation to be safety requirements and hygienic
January, dietary supplements can only
presented includes a free sale be advertised if the advertiser has norms. The public discussion phase
certificate, GMP certificate, closed on 26 December 2020. Based on
received approval from the Ministry of
composition, analytical Health of Belarus. This requirement its results, the draft resolution may
methodology, stability studies now be amended or rejected.
does not apply to outdoor and
(for products with a shelf life transport advertising. Dietary
greater than 24 months). AllYou can also read
