IADSA Week Sydney May 2019 - American Herbal Products Association
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IADSA NEWSFLASH | May 2019
May 2019
IADSA Week Sydney
The IADSA Annual Week was held this What came through loud and clear from All who participated went away with a
year in Sydney overlooking Harbour Bay. the three days is that the food renewed energy to contribute to building
Surely one of the world’s most supplement sector has a great story to the supplement sector’s shared story to
impressive locations for any meeting. tell, but that we need to work harder help create the most appropriate
This helped contribute to what many and smarter at how to tell it even regulatory and policy outcomes.
considered one of IADSA’s most better. Progress is being made in
rewarding Annual Weeks so far with a regulation, science and policy. But we Thanks in particular to our Australian
unique combination of discovering new still face a lack of understanding of the member association CMA for inviting us
approaches and skills and being brought value that supplements can bring to to Sydney and sharing some of the many
up to speed with the latest in regulatory, consumers, particularly among policy great things about Australia with us.
policy and market developments from makers.
across the world.
IADSA NEWSFLASH | May 2019
Regulatory new
5. Spirulina provisions, probiotics refer to living
3-4g microorganisms which are beneficial to
Function: Enhance immunity human health when ingested in
sufficient quantities. (As such)
Ingredients included in food raw probiotics are required to be living
materials directory are eligible for microorganisms.
health food filing (notification).
India
Claims Regulation: Change in the
air The Standard question
China State Administration for Market
ASEAN Regulation (SAMR) is consulting on
FSSAI is in the process of reviewing and
developing Microbiological Standards
adjustments to health food functions.
Almost there for various food commodities. In this
The authorities are considering to re-
regard, Microbiological Standards for
phrase 18 health functions by adding
Discussion continued early May in the nutraceutical products are currently
“help/aid” or similar terms to the
Task Force on ASEAN Regulatory under consideration by the Scientific
current wordings. 3 out of the current
Framework for traditional medicines Panel on Biological Hazards.
27 functional permitted claims could
and health supplements to see if a also be proposed for deletion. These
solution could be found to the include:1. Beautify/balance skin lipid, 2. Japan
concerns of Thailand regarding the Facilitate growth/improve growth
implementation of the GMP and 3.Stimulate lactation. GMO free: Japan to strengthen
Stability requirements. Thailand labelling requirements
considers that the two documents Further investigation on the
would be too challenging for their appropriateness of six borderline
From 2023 more stringent
small and medium sized companies. claims are also being considered: 1.
Assisting blood lipid reduction 2. Assisting requirements for food products using
blood sugar reduction 3. Assisting blood “free from GMO” labelling claims will
A ‘deferment’ clause was proposed to
pressure reduction 4. Assisting protection be implemented. The use of “free
address the Thai issue. Three options
against chemical injury of liver 5. from GMO” labelling claims will be
are now considered for reflection:
Protection against radiation hazards 6. restricted to foods which do not
Option 1 Deleting the deadline for Alleviating lead excretion contain GMO materials. New labelling
notification of deferral of
requirements will be imposed in cases
implementation of the two Annexes;
Companies had until end of April to where there is the possibility of cross
Option 2 (proposed by Indonesia) New
submit their comments. contamination.
text with cut-off date implementation
of the two Annexes; Option 3 Maintain
the original text of the Agreement. State Council passes draft rules on
implementing Food Safety Law
Member States are requested to
provide their feedback by 15 June. China's State Council has passed a draft
Should agreement be reached, the regulation on the implementation of
agreement would be ready for signing the Food Safety Law, detailing the
in September 2020. responsibilities of production operators
and governments as well as
accountability measures. Under the
China draft rules, companies involved in European Union
illegal activities will be subject to
Notification: 5 functional more severe punishment. The draft
Additives: 2019 plan revealed
ingredients under consideration also optimizes food safety standards
and risk monitoring systems so as to
China State Administration for Market ensure food safety and better protect Under EU legislation dating from 2008,
Regulation (SAMR) is considering to add the health of the people, according to the safety of all food additives
five new health food ingredients to its the State Council. authorised for use in the EU prior to 20
food raw materials directory: January 2009 must be re-evaluated.
The deadline for completion of the re-
Proposed changes to probiotics
1.Coenzyme Q10 evaluation of all food additives is 2020.
30-50mg Having this deadline in mind, EFSA has
Function: Enhance immunity
The SAMR has recently issued draft recently published its 2019 tentative
Provisions for Declaration and Review work programme which will include a
2. Melatonin of Probiotic Health Food. At the review of number of additives
Amount 1-3mg moment, the declaration and review of permitted for use in food supplements.
Function: Sleep improvement probiotic health food is based on an These include:
earlier draft named Provision for § Hydrochloric acid and chlorides
3. Fish oil Declaration and Review of Probiotic
No more than 4.0g (among them, the usage E 507-509; E 511
Health Food (Trial), which was § Phosphoric acid, phosphates
amount of EPA+DHA should be no less than
implemented in 2005. The new draft and polyphosphates E 338-341;
1.0g)
Function: Assist to reduce serum requires minimum levels of active E 343; E 450-452
triglycerides probiotics, raw material inspection § Sulphuric acid and sulphates E
reports, research reports, scientific 513 - E 517
4. Reishi shell-broken spore powder literature and other evidence § Tartaric acid and tartrates E
1-4g related to probiotic functions based on
Function: Enhance immunity 334 - 337, 354
specific strains. Under the proposedIADSA NEWSFLASH | May 2019
§ Esters of mono and diglycerides since no data was submitted during exposure of workers, consumers and
of fatty acids E 472 a-f these four years to demonstrate the the environment to the additive.
§ Polyvinylpyrrolidone, safety of the substance, its prohibition The food additive is used in many
polyvinylpolypyrrolidone E 1201 was inevitable. different food products for its
-1202 colouring and opacifying properties.
§ Polydextrose E 1200 E200/ E202: ADI up!
§ Dimethyl polysiloxane E 900 https://www.anses.fr/en/system/files/ERC
A2019SA0036.pdf
EFSA has confirmed the exchange of
Further breaking down trade the temporary group ADI of 3 mg sorbic
acid/kg bw per day for sorbic acid (E France/ EU: An unavoidable clash –
barriers or not - over titanium dioxide
200) and its potassium salt (E 202) to a
new group ADI of 11 mg sorbic acid/kg
The EU has recently strengthened its
bw per day. This increase is based on The French authorities have decided to
principle of mutual recognition. A
the findings of an extended one- go ahead with the ban of the use of
faster problem-solving procedure was
generation reproductive toxicity study titanium dioxide in foods including
introduced in March for disputes
(EOGRTS) provided as a follow-up to food supplements. This ban, to start
between companies and national
the conclusions and recommendations from 1 January 2020, is based on the
authorities to prove lawful marketing
of the 2015 EFSA Panel opinion. precautionary principle after the
in an EU Member State.
French food safety agency, ANSES,
#EUandMyFood campaign recently indicated that uncertainties
The Mutual recognition procedure aims
remain as to the safety of the additive.
to ensure market access for products
that are not subject to EU EFSA is raising awareness of how the
EU food safety system enhances the The French decision will be addressed
harmonisation. It helps guarantee that
lives of citizens. The campaign with the European Commission and
any product lawfully sold in one EU
#EUandMyFood will run from 24 April Member States mid-May. Nine
country can be sold in another.
to 26 May 2019 to capitalise on the consumer groups have recently written
increased attention on the EU due to a letter to the European Commission
https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32019R05 the upcoming European Parliament requesting it not to raise any
15&from=EN elections in May. objections or initiate any legal
proceedings against the French
https://www.youtube.com/watch?v=5H6h2 measure.
Rethinking support to SMEs
gwPgbo&feature=youtu.be
Will the European Commission follow
EFSA has launched new support the demands of these consumer
Glutamates: Call for help
initiatives dedicated to small and groups? This remains to be seen. The
medium-sized enterprises (SMEs). SMEs impact of the French decision on the
EFSA is seeking additional data to
will now be able to access support supplement sector range from €20,000
complete its risk assessment on six
from EFSA when preparing, submitting for the smaller companies to
glutamate additives (glutamic acid (E
and monitoring their applications. €148,000,000 for the bigger one.
620), monosodium glutamate (E 621),
monopotassium glutamate (E 622),
EFSA will use the experience gained in
calcium diglutamate (E 623), Swelling concerns over joint heath
providing these new forms of support
monoammonium glutamate (E 624) and substances
to decide whether to include them in
magnesium diglutamate (E 625)).
its catalogue of support initiatives.
Companies are requested to supply Following the recently published
https://www.efsa.europa.eu/en/press/ne EFSA with information on use levels, opinion on the risks associated with
ws/190402 function and technological need of the consumption of food supplements
food additives and data on the lowest containing glucosamine and/or
Contaminants under EFSA achievable limits for the impurities of chondroitin sulphate, the French food
toxic elements. safety agency ANSES has called for
microscope
measures be taken to better inform
https://ec.europa.eu/food/sites/food/files consumers about the risks associated
EFSA is to collect all available data on /safety/docs/fs_food-improvement-e620-
the occurrence of chemical with the consumption of these
625_glutamates_201904113_e422_data.pdf
contaminants in food and feed. products. Diabetic and pre-diabetic
National food authorities, research individuals, pregnant and
France breastfeeding women should not
institutions, academia, food business
operators and other stakeholders are consume such food supplements, said
invited to submit data by 1 October. Titanium Dioxide: ANSES in doubt the Agency.
More information at: once again
www.efsa.europa.eu/en/consultations/call ANSES also considers it necessary that
/190410 Following the expert appraisal work it the maximum authorised daily doses of
conducted in 2017, the French Food glucosamine and chondroitin sulphate
“No” to Yohimbe Agency, ANSES, was asked in February in food supplements be harmonised at
2019 to review the most recent studies the European Union level.
The EU decision to prohibit the use of on the oral toxicology of titanium
https://www.anses.fr/en/content/certain-
Yohimbe is now official. Yohimbe and dioxide (E171) and to update its
food-supplements-joint-pain-should-be-
its preparations had been placed under recommendations. The Agency avoided-risk-populations
Union scrutiny due to scientific concluded in April that it had not
uncertainty on its harmful effects on obtained any new information to
health. The European Commission had resolve the uncertainties regarding the
four years to decide whether to ban it safety of the additive. ANSES
or remove it from scrutiny. However, reiterated the need to limit theIADSA NEWSFLASH | May 2019
Ireland January 2015 and will become the only Version 3”. The objective of this
reference register in future as it will guideline is to present the SFDA’s
be updated monthly with all new current view on specific products or a
Ireland taps new DNA technology
notifications. The second, Transitional category of products (including
for food fraud Register of Food Supplements, includes supplements) and whether they should
food supplement products that were be under the responsibility of Saudi
The Food Safety Authority of Ireland notified from 2008 to 31 December Food and Drug Authority and
(FSAI) has disclosed that it now has a 2014 via the previous notification particularly where the regulation could
new scanning tool that can identify the system. This register will no longer be fall on the borderline between two
entire DNA content of a food. The way updated and will expire after 30 June SFDA sectors.
the tool works is that it compares 2019.
actual ingredients in a food ingredient https://www.sfda.gov.sa/ar/oper/Docume
identified by their DNA profile against nts/SFDA-products-classification-
the ingredients that are displayed on Switzerland guidance.pdf
the label.
Balancing the risk for VMs
“It is now possible to scan the entire supplements
DNA content of a food without any
prior knowledge or suspicion of what Switzerland aims to no longer allow in
may or may not be present in that food supplements nutrients (such as
food,” said FSAI. The tool has recently vitamin A) that may have health
been used on 45 plant-based foods and consequences in cases of over-dosages.
food supplements from Irish health Conversely, maximum amounts will be
food shops and supermarkets. removed for non-problematic
substances such as vitamin B1. USA
https://www.fsai.ie/news_centre/press_re
leases/DNA_based_food_scanning_tool_180
22019.html Compliance with Intentional
Adulteration Rules: The clock is
Norway ticking
Fluoride: Find the limits Routine inspections to verify
compliance with the Intentional
Adulteration (IA) rules will begin in
The Norwegian Food Safety Authority
has requested its Scientific Committee March 2020 has announced by the FDA.
for Food Safety to evaluate the The IA rule, issued under FDA’s Food
maximum level of fluoride for use in Saudi Arabia Safety Modernization Act (FSMA)
food supplements. This assessment authority, is designed to address
should particularly consider the safety hazards that may be intentionally
Requirements for Herbal & Health introduced to foods, including by acts
of fluoride from fluoride tablets / Products Submission discussed of terrorism, with the intent to cause
dental care products at daily levels of
0.5, 1, 5 and 7 mg/day. widespread harm to public health.
The Saudi Food and Drug Authority Food facilities covered by the rule will
(SFDA) has published draft be required to develop and implement
In 2017 Norway published an “Requirements for Herbal & Health a food defense plan that identifies
amendment that has led to the Product Submissions”. The guideline
deletion of most of the maximum vulnerabilities and mitigation
provides recommendations on the strategies for those vulnerabilities.
levels for vitamins and minerals documentation requirements for the
including the limits of fluoride at 0.5 registration of herbal & health
mg per day. The reason for these FDA unveils new tool for unlawful
products. The SFDA has divided natural
deletions was that those levels were ingredients
herbal and health products into two
not established based on the criteria classes:
defined in the EU food supplement § Class A: refers to heath supplements
The FDA is launching a new tool to
directive. where the marketing authorisation quickly alert the public when they
holder (MAH) is required to submit a become aware of ingredients that
Italy partial application in order to meet appear to be unlawfully marketed in
certain requirements of quality and dietary supplements.
safety (e.g. multi-vitamin products).
Notification register: time to tidy § This Dietary Supplement Ingredient
up § Class B: refers to herbal and health Advisory List is housed on the FDA
products where the MAH is required
to submit a complete application in
website. The FDA emphasised that the
The Italian Ministry of Health has order to meet the requirements List is not exhaustive and it will always
recently requested that ‘all food quality, safety and efficacy. be a work in progress. Ingredients will
supplement products notified up to be added to the list following an initial
2014 in Italy, must be re-notified with FDA assessment indicating the
https://www.sfda.gov.sa/ar/drug/resource
the new online procedure “NSIS Foods s/DocLib2/Requirements-herbal-health-
ingredient may not lawfully be sold in
subject to notification” by 30 June submission(draft).pdf dietary supplements.
2019.’ The Ministry of Health has
currently published 2 separate https://www.fda.gov/food/dietary-
Product Classification Guidance: supplement-products-ingredients/dietary-
registers on its website of notified food
where responsibility lies supplement-ingredient-advisory-list
supplements: The first, Register of
Food Supplements, includes food
supplement products notified from 1 SFDA has recently published the Saudi
FDA Products Classification Guidance,IADSA NEWSFLASH | May 2019
Food (supplements) for thought need to be developed following calls (No. 1717-2016) proposing that food
for data. ANVISA has stressed that the supplements, known as ‘dietetic
The Food and Drug Administration fact that an ingredient is specified in products’ in Peru, fall under food
(FDA) is having a public meeting mid some recognized reference does not jurisdiction. Once the Bill is approved
May entitled “Responsible Innovation mean that is safe. ANVISA will publish and signed, responsibility for food
in Dietary Supplements”. On February, the draft document that will then be supplements will be transferred from
the FDA announced new efforts to available for comments for 60 days. the General Directorate of Medicines,
strengthen the regulation of dietary Supplies and Drugs (DIGEMID to the
http://portal.anvisa.gov.br/documents/21 General Directorate of Environmental
supplements by modernizing and
9201/4340788/Documento+Orientador.pdf/ Health (DIGESA).
reforming its oversight. The purpose of 85dd1d7d-5687-43c3-b960-e6f8ff6c925f
the public meeting is to give interested
parties an opportunity to present ideas
for facilitating responsible innovation
Honduras
in the dietary supplement industry.
Confusion over supplement
categorisation
The Sanitary Regulation Agency (ARSA)
has opened for comments two draft
Regulations: one for food products and
the other for pharmaceutical products, Eurasian Economic Union
both covering food supplements known (EAEU)
as nutritional supplements in
Honduras. It is unclear how the Gelatine fish oil capsules get
Argentina supplements will be regulated in exempt from veterinary control
future: whether under the food law or
New look at supplement rules pharmaceutical law, or under both The Eurasian Economic Commission
legislations depending on the (EEC) has recently excluded gelatine-
Argentina resumed its work to update composition of the supplement. coated fish oil capsules from the
the rules for the food supplement veterinary control when imported into
category. In April, the National Mexico the EAEU territory.
Commission of Foods opened for
comments a new draft regulation for COFEPRIS revokes guidelines for New classification is up for
food supplements. it is worth recalling the use of cannabis in food preparations containing probiotic
that during 2015 a draft was issued but products microorganisms
it was put on hold. The main changes
to current rules cover the revision of The sanitary authorities from the By the EEC Board's Resolution 56 of 16
the maximum limits for vitamins and Federal Commission for the Protection April 2019, preparations based on
minerals. Minimum level for vitamins Against Sanitary Risks (COFEPRIS) has living lactic acid bacteria that are used
and minerals would be increased from revoked the guidelines and criteria for for maintaining and managing the
20 to 30%. The permitted botanical list assessing the use of cannabis, including human gastrointestinal microbiota,
could also be cut from 35 to 27 in food supplements, issued in October shall be classed under EAEU FEACN
species. 2018. COFEPRIS has stressed that the Subheading 3002 90 500 0 (cultures of
use of cannabis is only approved with microorganisms) The resolution enters
Brazil medical and scientific purposes. into effect on 19 May 2019.
Contaminants: Under the spotlight MERCOSUR Ukraine
From April to January 2020, ANVISA New labelling law to come into
Alignment with Codex GSFA
will be collecting data on the force
concentration of contaminants in foods
marketed in Brazil, in order to help Work to revise and update the
Mercosur harmonised list (based on The Ukrainian Law on Food Information
define or update maximum limits of 31
Codex) – including additives used in to Consumers of December 2018
food contaminants. The list of
supplements - has now been finalised. (officially published in February) will
contaminants was determined after
Suggestions made by Brazil to include come into force in August 2019.
considering the following international
additives evaluated by JECFA but not The new law, aimed at harmonising
regulatory references: Codex
yet included in the GSFSA was not Ukraine’s food labelling requirements
Aimentarius, European Union, United
followed by the other Member States. with EU standards, introduces
States, Canada, Japan, Australia and
Mercosur is a trade bloc composed of requirements for the labelling of foods
New Zealand.
Argentina, Brazil, Paraguay, Uruguay including dietary supplements. In
and recently Bolivia. Venezuela’s particular, the law introduces general
Specifications for supplement food labelling provisions. A three-year
membership is currently suspended for
ingredients: how to fill the gaps grace period is foreseen during which
political reasons.
products conforming to the previous
ANVISA is discussing criteria for laws may continue to be manufactured
defining specifications of food Peru and/or put on the market until August
supplement ingredients not covered by 2022. Such foods may remain on the
the 10 the international references Food supplements to become foods market until their shelf life expires.
recognized by the Agency. Where no
standardized and validated The Health Commission of the Peruvian
specifications exist, specifications will Parliament approved in March a BillFocus on Titanium Dioxide Titanium dioxide (TiO2),
also known as E171, is the
While EFSA stated in its 2016 opinion that TiO2 poses
no health concerns, a 2017 French scientific study
The legal basis proposed by France to ban TiO2 is included in Articles L521-17 of the French Consumer Law
and 54 of the EU General Food Law that are both based on the presence of grave or immediate danger to be
Steps towards the decision to most widely used white
pigment because of its
from the French National Institute for Agricultural
Research (INRA) highlighted potential carcinogen
justifed. Article L521-17
brightness and opacity. The risks of nanoparticles of TiO2. This led the French
ban the use of the additive in additive is permitted for use
in supplements and other
National Assembly to pass an amendment to the
Farm and Food Bill signed in October 2018 (so called
• In case of grave or immediate danger, the ministers in charge can suspend for a maximum of
one year the production, import, export, marketing (incl. free samples) of a product and can
foods (including supplements) foods at quantum satis. EGALIM Law) aiming to ban the use, import and proceed to the recall or destruction when this is the only means to cease the danger.
marketing of TiO2 and any food containing it. This • Products can be marketed again when they are compliant to the law in force.
ban requires a ministerial implementing order • Possibility to extend the suspension for an additional 1 year period.
in France before it can be applied.
September 2016 January 2017 April 2017 March 2018 July 2018 October 2018 January 2019 February 2019 12 April 2019 25 April 2019 26 April 2019 3 May 2019 13 May 2019
Re-evaluation of TiO2 as a The European Commission (EC) The French Agency for Food, The European EFSA organised a The French France reaffirmed its ANSES launched a call ANSES published its new opinion on French Order suspending the France notifies the 9 consumer groups EU discussion with
food additive: As part of its launched a call for data on Environmental and Occupational Commission requested hearing with the Parliament willingness to ban TiO2. In for information on the the safety of the additive based on a use of TiO2 in France published European called for an EU- Member States on the
re-evalution programme of all TiO2, inviting food companies Health & Safety (ANSES) EFSA to carry out a scientific authors of adopted the order to obtain the use of manufactured literature review on the oral toxicity in the French Official Journal. Commission wide ban of TiO2 emergency measure
additives permitted for use in to generate the additional released its opinion on whether scientific evaluation the studies and EGALIM Law. necessary legal conditions nanomaterials in food of E171. 25 new studies published The decision enters into force and for the European regarding titanium
the European Union before data requested by EFSA in its the INRA findings (NANOGUT of four new concluded that the The law for this prohibition, the related to a number of since 2017 were identified. as of 1 January 2020 for a Commission not to dioxide when used as a
2009, the European Food opinion of 2016. In particular, study) provided evidence to studies relating to the outcome of the studies foresees the French Ministry in charge food additives. This According to ANSES, some of these period of 1 year. It is based on oppose to the ban in food additive (E171)
Safety Authority (EFSA) data on particle size and reconsider the potential toxicity of did not merit re- suspension of indicated that ANSES would list includes TiO2, studies revealed new signals, such as the application of the France. The groups
concluded that available data particle size distribution were conclusions of the 2016 EFSA re- TiO2 and to indicate opening its existing the use be asked to magnesium salts of changes in cellular biological precautionary principle in also urged the
on TiO2 in food did not to be submitted by June 2018. evaluation concerning the safety whether they would opinion of TiO2 and its update its opinion on fatty acids mechanisms in mice or accordance with article L 521- Commission not to
indicate safety concerns. A dietary Extended One- of TiO2. In its conclusions, merit reopening use in food nanoparticles in relation to (E470b), silicon developmental abnormalities in 17 of the French Consumer raise any objections
EFSA recommended that new Generation ANSES points out that although the existing opinion of products TiO2 by 15 April. This dioxide (E551) and invertebrates, as well as in vitro Code, which requires a grave or initiate any legal
studies be carried out to fill ReproductiveToxicity Study the results presented in this EFSA on the safety of assessment should be many other additives. genotoxic effects via oxidative stress and immediate danger to be proceedings against
data gaps on possible effects with the food additive would publication do not currently call TiO2 as a food based on new studies (effects identified for different forms demonstrated. the French measure.
on the reproductive system, need to be generated by into question EFSA’s assessment, additive available. On the basis of of the nanoparticle TiO2, including
which could enable the August 2019. The Titanium the study does demonstrate this ANSES report, the E171). However, none of these new
Authority to set an Acceptable Dioxide Manufacturers effects that had not been Government would refer the studies were able to confirm or
Daily Intake (ADI). EFSA also Association (TDMA) identified so far, specifically matter to the European refute the potential carcinogenesis-
noted that there are no set committed to carrying out this potential promoting effects for Commission. The Minister promoting effect of E171 reported in
limits for the particle size of study. carcinogenesis. As a result, ANSES planned to exercise his right the NANOGUT study. The agency
TiO2 in the EU specifications. highlights the need to conduct of safeguard highlighted again the lack of
Additional data would be studies to fully characterise the by taking a unilateral scientific data able to resolve the
required to update the potential health effects related decision prohibiting TiO2. uncertainties regarding the safety of
specifications. to ingestion of TiO2, with a the additive E171. It emphasised the
methodology and schedule to be need to obtain data for
defined. characterising the different physico-
chemical forms of E171 and
additional toxicological data on the
The authors of a study carried potential effects associated with
out by INRA concluded that their ingestistion.
chronic exposure of rats
toTiO2 via the oral route may
cause precancerous colorectal
lesions. The findings do not,
however, enable conclusions
to be drawn on the effects of
TiO2 in humans.You can also read
