EU regulations for manufacture and sale of nutraceuticals. PPT

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EU regulations for manufacture and sale
of nutraceuticals


1. European Union Directives and
Regulations for manufacture
and sale of Nutraceuticals and
Dietary Supplements

2. Nutrition Labelling


The General Food Law Regulation 178/2002

• 2000 White Paper on Food Safety
• Announced about 80 proposals for new and improved legislation in this field,

covering a legal framework for foods with functional properties.
• Nutraceuticals and functional foods have no specific legal status till this time.
• The “General Food Law Regulation” 178/2002 contains the foundation of

European Food Law.
• The Regulation applies to all foodstuffs and defines “food” (or “foodstuff”) as-

“any substance or product, whether processed, partially processed or
unprocessed, intended to be, or reasonably expected to be ingested by humans.”

• In the area of “nutraceuticals,” relevant European legislation where the risk
assessment risk management process is well developed includes the areas of food
supplements and fortified foods.


The Food Supplements Directive 2002/46

• Definition of Food Supplements: “Foodstuffs the purpose of which is to
supplement the normal diet and which are concentrated sources of nutrients or
other substances with a nutritional or physiological effect, alone or in
combination, marketed in dose form, namely forms such as capsules, pastilles,
tablets, pills and other similar forms, sachets of powder, ampoules of liquids,
drop dispensing bottles, and other similar forms of liquids and powders
designed to be taken in measured small unit quantities.”

• Important element is that food supplements may contain substances with a
nutritional or physiological effect.

• Substances possessing physiological, but non-medicinal properties could be
regulated outside medicinal law.

• The product must be in a concentrated form, presented in measured small unit
quantities to fall under food supplements law .

• The Directive represents a first step in the harmonization process as it focuses
only on vitamins and minerals.


Food supplement Regulations
• legislation on fortified foods (Regulation 1925/2006),
• on nutrition and health claims (Regulation 1924/2006),
• on novel foods (Regulation 258/1997,
• on mutual recognition (Regulation 764/2008) would already constitute useful

tools to harmonize specific aspects of the products concerned
• Upper Tolerable Safe Intake Levels (UL) of the vitamins and minerals are set by

the Scientific Committee on Food (SCF) and later by its successor, EFSA.(The UL
is the intake level that can be consumed daily over a lifetime without being
likely to pose any risk to health according to available evidence)


Regulation 1924/2006 on the addition of vitamins and
minerals and other substances to food (fortified foods)

• Maximum amounts are set for vitamins and minerals whose
reference intakes for the population are close to the upper safe
levels, the contribution of individual products to the overall diet of
the population in general or of sub-groups of the population and the
nutrient profile of the product established as provided for by
Regulation 1924/2006 on claims will also be taken into account, as


Regulation 1924/2006 on nutrition and health claims
made on foods

• Nutrition claims would only be possible if they are included in the
annex to the text.

• Health Claims based on generally accepted scientific data can only
be allowed when included on a list.

• Other Health Claims, Reduction of Disease Risk Claims, and Health
Claims referring to Children’s Development and Health can only be
allowed after submission of a file to EFSA and approval through the
Standing Committee.



• Food supplements are concentrated sources of nutrients N
(i.e. mineral and vitamins) or other substances with a T
nutritional or physiological effect that are marketed in R
“dose” form (e.g.pills,tablets,capsules, liquids in measured
doses). O

• Food supplements are intended to correct nutritional D
deficiencies, maintain an adequate intake of certain U
nutrients, or to support specific physiological C
functions.They are not medicinal products

• In the EU, food supplements are regulated

as foods.
Harmonised legislation regulates the vitamins and O

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• Companies wishing to market a nutrient source not O
included in the permitted list have to submit an L
application to the European Commission. Under

Directive 2002/46/EC.

• European Commission reviews and updates the list of vitamin or
mineral substances that may be used in food supplements.

• EFSA is requested to provide a scientific opinion on its safety F

according to Regulation (EC) No 2015/2283 on novel foods.

• EFSA has performed a comprehensive evaluation of the possible

adverse health effects of individual micronutrients at intakes exceeding F
the dietary requirements and, where possible, established tolerable S
upper intake levels (ULs) for different population groups.



• The objective of the harmonised rules on those products in Directive
2002/46/EC is to protect consumers against potential health risks from O
those products and to ensure that they are not provided with B
misleading information.

• With respect to the safety of food supplements, the Directive lays E

down a harmonised list of vitamins and minerals that may be added for
nutritional purposes in food supplements (in Annex I to the C

• Annex II of the Directive contains a list of permitted sources (vitamin I

and mineral substances) from which those vitamins and minerals may be
manufactured. V



• This list has been amended by the following Regulations and Directive
to include additional substances:

oCommission Regulation (EU) 2017/1203
o Commission Regulation (EU) 2015/414
oCommission Regulation (EU) No 119/2014 o

Commission Regulation (EU) No 1161/2011
o Commission Regulation (EC) No 1170/2009
o Commission Directive 2006/37/EC

• The trade of products containing vitamins and minerals not listed in
Annex II has been prohibited from the 1st of August 2005.

• Directive 2002/46/EC has been aligned with the new Regulatory
Procedure with scrutiny by Regulation (EC) No 1137/2008.


• Food supplements that are marketed in a EU Member State have to A

comply with all relevant aspects of EU food legislation and any
specific EU Member State national legislation in terms of their N
composition, manufacture and control.


• Manufacturing Facility should meet the specific needs of the food F
supplement industry in relation to GMP, with special attention paid A
to the requirements of EU food legislation.


• It should covers the complete cycle of production and quality T
control of a food supplement, from the acquisition of all materials U
through all stages of subsequent-

• processing, packaging and storage to the distribution or release of

the finished product. I


• Relevant sections of the documents apply also to food

supplement companies whose products are contract A
manufactured and also to those who are solely distributors of N

• The food supplement supply chain should ensure that the relevant F

sections are complied with.
For example, distributors should undertake audits on the A
manufacturers to ensure compliance with good manufacturing


• Manufacturers and distributors of food supplements should

comply with all relevant EU and specific national legislation in U
their home country. R
And also that of any EU countries to which they export their
products. I



• EU legal requirements on food hygiene apply also to food

supplements that are manufactured in a EU Member State for A
direct export to countries outside of the EU.




Registration –

Before registration, the variety’s identity is tested for:
• Distinctness
• Uniformity
• Stability

Article 1- (As of Official Journal of the European Communities) A

1. This Directive concerns food supplements marketed as foodstuffs

and presented as such.These products shall be delivered to the E
ultimate consumer only in a pre-packaged form.

2. This Directive shall not apply to medicinal products as defined by
Directive 2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community code relating to
medicinal products for human use.


Nutrition Labelling in EU

• Food supplements are concentrated sources of nutrients or other
substances with a nutritional or physiological effect.

• People take supplements to correct nutritional deficiencies, ensure
that they take in enough of certain nutrients, or to support specific
physiological functions.

• Food supplements are designed to be taken in small quantities and
are sold in different forms, such as:
• capsules
• powder sachets
• drop dispensing bottles
Whether you manufacture, sell or import food supplements, you
need to ensure that the product complies with EU rules


Labelling requirements
• Food supplements must comply with general food labelling rules and display:
• portion of the product recommended for daily consumption
• warning not to exceed the recommended daily dose
• statement that food supplements should not be used as a substitute for a balanced diet
• statement that the product should be stored out of the reach of young children.
• The labelling, presentation or advertising of food supplements are forbidden from featuring

claims that the product prevents, treats or cures a disease.
• The labelling shall bear the following particulars:(Directive 2000/13/EC)
• (a) the names of the categories of nutrients or substances that characterise the product or an

indication of the nature of those nutrients or substances;
• (b) the portion of the product recommended for daily consumption;
• (c) a warning not to exceed the stated recommended daily dose;
• (d) a statement to the effect that food supplements should not be used as a substitute for a

varied diet;
• (e) a statement to the effect that the products should be stored out of the reach of young





1. The amount of the nutrients or substances with a nutritional or
physiological effect present in the product shall be declared on the
labelling in numerical form. The units to be used for vitamins and
minerals shall be those specified in Annex I.
Rules for implementing this paragraph may be specified in accordance
with the procedure referred to in Article 13(2).
2. The amounts of the nutrients or other substances declared shall be
those per portion of the product as recommended for daily
consumption on the labelling.
3. Information on vitamins and minerals shall also be expressed as a
percentage of the reference values mentioned, as the case may be, in
the Annex to Directive 90/496/EEC


Dietary Reference Values for the EU population as derived by the EFSA Panel on
Dietetic Products, Nutrition and Allergies (NDA)

• The term Dietary Reference Value (DRV) is an umbrella term for the complete set of
nutrient reference values which include, among others, concepts like the Population
Reference Intakes, the Average Requirements, Adequate Intakes and Reference Intake
ranges for macronutrients (EFSA NDA Panel, 2010), which indicate the amount of an
individual nutrient that people need for good health depending on their age and

• EFSA used four types of DRVs:
• The Population Reference Intake (PRI), which is the level of (nutrient) intake that is

adequate for virtually all people in a population group. On the assumption that the
individual requirements for a nutrient are normally distributed within a population and
the interindividual variation is known, the PRI is calculated on the basis of the AR plus
twice its standard deviation (SD). This will meet the requirements of 97.5% of the
individuals in the population.

• The Average Requirement (AR), which is the level of (nutrient) intake estimated to
satisfy the physiological requirement or metabolic demand, as defined by the specified
criterion for adequacy for that nutrient, in half of the people in a population group,
given a normal distribution of



DRV for EU
• The Adequate Intake (AI), which is the value estimated when a PRI cannot be

established because an AR cannot be determined. An Adequate Intake is the
average observed or experimentally determined approximations or estimates of
nutrient intake by a population group (or groups) of apparently healthy people
that is assumed to be adequate. The practical implication of an AI is similar to
that of a PRI, i.e. describe the level of intake that is considered adequate for
health reasons. The terminological distinction relates to the different way in
which these values are derived and to the resultant difference in the “firmness”
of the value.

• • The Reference Intake range (RI), which is the intake range for macronutrients,
expressed as % of the energy intake. These apply to ranges of intakes that are
adequate for maintaining health and associated with a low risk of selected
chronic diseases.

• The detailed reasoning for establishing individual values can be found in the

20 related opinions of the NDA Panel.



• Food Supplement Europe Guide

• European Food Safety Authority

• Official website of the European Union




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