Algae and algae products - Food and feed applications: General overview of limits, procedures and analytical methods

This Technical Report describes quality designations and indications for algae and directly derived products from algae production required for or by food/feed/nutraceuticals/animal food producers and industry. This TR does not apply to pharmacuetical, cosmetics and chemical applications.  
Note: This TR does not provide instructions on existing handling of technical requirements in existing legislations.

Alge in izdelki iz alg - Uporaba hrane in krme: Splošni pregled omejitev, postopkov in analitskih metod

General Information

Status
Published
Public Enquiry End Date
30-Nov-2020
Publication Date
16-Mar-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Mar-2021
Due Date
16-May-2021
Completion Date
17-Mar-2021

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SLOVENSKI STANDARD
SIST-TP CEN/TR 17559:2021
01-maj-2021

Alge in izdelki iz alg - Uporaba hrane in krme: Splošni pregled omejitev, postopkov

in analitskih metod

Algae and algae products - Food and feed applications: General overview of limits,

procedures and analytical methods
Ta slovenski standard je istoveten z: CEN/TR 17559:2021
ICS:
67.040 Živilski proizvodi na splošno Food products in general
SIST-TP CEN/TR 17559:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 17559:2021
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SIST-TP CEN/TR 17559:2021
CEN/TR 17559
TECHNICAL REPORT
RAPPORT TECHNIQUE
March 2021
TECHNISCHER BERICHT
ICS 13.020.55; 65.120; 67.040
English Version
Algae and algae products - Food and feed applications:
General overview of limits, procedures and analytical
methods

This Technical Report was approved by CEN on 4 January 2021. It has been drawn up by the Technical Committee CEN/TC 454.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 17559:2021 E

worldwide for CEN national Members.
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CEN/TR 17559:2021 (E)
Contents Page

European foreword ...................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 7

2 Normative references .................................................................................................................................... 7

3 Terms and definitions ................................................................................................................................... 7

4 Product specifications ................................................................................................................................... 7

4.1 General ................................................................................................................................................................ 7

4.2 Food ..................................................................................................................................................................... 7

4.3 Feed ...................................................................................................................................................................... 8

4.4 Type of product specification documents .............................................................................................. 8

4.4.1 General ................................................................................................................................................................ 8

4.4.2 Technical Data Sheet (TDS) ......................................................................................................................... 9

4.4.3 Certificate of Analysis (CoA) ....................................................................................................................... 9

4.4.4 Product data sheet (PDS) ............................................................................................................................. 9

4.4.5 Raw Material Specification (RMS)............................................................................................................. 9

4.4.6 Material Safety Data Sheet (MSDS) ........................................................................................................... 9

5 Product characteristics ................................................................................................................................. 9

5.1 Purity ................................................................................................................................................................... 9

5.1.1 General ................................................................................................................................................................ 9

5.1.2 Physical foreign matter .............................................................................................................................. 10

5.1.3 Other algae, bacteria or organic materials .......................................................................................... 10

5.1.4 Algae from other location .......................................................................................................................... 11

5.1.5 Methods of analysis ...................................................................................................................................... 11

5.2 Contamination................................................................................................................................................ 12

5.2.1 General .............................................................................................................................................................. 12

5.2.2 Food ................................................................................................................................................................... 12

5.2.3 Feed .................................................................................................................................................................... 13

5.2.4 Common issues in food and feed for other contaminants .............................................................. 13

6 Other relevant product information ...................................................................................................... 14

6.1 Origin ................................................................................................................................................................. 14

6.1.1 General .............................................................................................................................................................. 14

6.1.2 Country of origin and place of provenance .......................................................................................... 15

6.2 Labelling ........................................................................................................................................................... 15

6.3 Verification and claims ............................................................................................................................... 16

6.4 Traceability ..................................................................................................................................................... 16

6.5 Chain of Custody ............................................................................................................................................ 16

6.6 Sustainable development ........................................................................................................................... 16

6.6.1 General .............................................................................................................................................................. 16

6.6.2 The United Nations Sustainable Development Goals ....................................................................... 17

7 Algae and algae products as Novel Food ............................................................................................... 17

7.1 Procedure ........................................................................................................................................................ 17

7.2 Methods of analysis ...................................................................................................................................... 17

Annex A (informative) Examples of product specification documents .................................................. 18

Annex B (informative) Purity identification methods and gap analysis algae .................................... 22

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Annex C (informative) Mapping of currently existing legislation on maximum allowed levels

of elements and other chemical contaminants in food and feed applications ....................... 25

Annex D (informative) Applicability of standards to determine the safety of novel algae and

algae food products to comply with the Novel Food Regulation (EU) No 2015/2283 ......... 28

Bibliography ................................................................................................................................................................. 35

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European foreword

This document (CEN/TR 17559:2021) has been prepared by Technical Committee CEN/TC 454 “Algae

and algae products”, the secretariat of which is held by NEN.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

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Introduction

This document has been prepared by the experts of CEN/TC 454 'Algae and algae products'.

The European Committee for Standardization (CEN) was requested by the European Commission (EC) to

draft European standards or European standardization deliverables to support the implementation of

Article 3 of Directive 2009/28/EC for algae and algae-based products or intermediates.

This request, presented as Mandate M/547 , also contributes to the Communication on “Innovating for

Sustainable Growth: A Bio economy for Europe”.

The former working group CEN Technical Board Working Group 218 “Algae”, was created in 2016 to

develop a work programme as part of this Mandate. The technical committee CEN/TC 454 'Algae and

algae products' was established to carry out the work programme that will prepare a series of standards.

The interest in algae and algae-based products or intermediates has increased significantly in Europe as

a valuable source including but not limited to, carbohydrates, proteins, lipids, and several pigments.

These materials are suitable for use in a wide range of applications from food and feed purposes to other

sectors, such as textile, cosmetics, biopolymers, biofuel and fertilizer/biostimulants. Standardization was

identified as having an important role in order to promote the use of algae and algae products.

The work of CEN/TC 454 should improve the reliability of the supply chain, thereby improving the

confidence of industry and consumers in algae, which include macroalgae, microalgae, cyanobacteria,

Labyrinthulomycetes, algae-based products or intermediates and will promote and support

commercialisation of the European algae industry.

This document has been prepared in close collaboration with the CEN/TC 454 working groups. The

European standards and technical reports developed in this mandate include:
CEN/TC 454/WG 1 Terminology

— CEN/TR 17559, Algae and algae products - Food and feed applications: General overview of limits,

procedures and analytical methods
CEN/TC 454/WG 2 Identification

— EN 17477, Algae and algae products – Identification of the biomass of microalgae, macroalgae,

cyanobacteria and Labyrithulomycetes - Detection and identification with morphological and/or

molecular methods
CEN/TC 454/WG 3 Productivity

— EN 17480, Algae and algae products - Methods for the determination of productivity of algae

growth sites
CEN/TC 454/WG 5 Specifications for non-food/feed sector applications

— CEN/TR 17611, Algae and algae products - Specifications for cosmetic sector applications

— CEN/TR xxx, Algae and algae products - Specifications for chemical and biofuel applications

— CEN/TR 17612, Algae and algae products - Specifications for pharmaceutical sector applications

http://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=refSearch.search.

Under preparation. Stage at the time of publication: prEN 17477.
Under preparation. Stage at the time of publication: prEN 17480.
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CEN/TC 454/WG 6 Product test methods

— EN xxx, Algae and algae products - Methods of sampling and analysis - Determination of total

lipids using the Ryckebosch-Foubert method

— EN 17605, Algae, algae products and intermediates - Methods of sampling and analysis - Sample

treatment

— EN xxx, Algae and algae products – Methods of sampling and analysis – quantification of

chlorophyll

The available EU directives and other ISO and CEN standards which are of relevance for algae and algae

products for food and feed applications are listed in the bibliography.
Under preparation. Stage at the time of publication: prEN 17605.
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1 Scope

This document describes product specifications, product characteristics and other relevant information

for algae and algae products for food, nutraceutical and animal feed applications. This document is a

general overview of available limits, procedures and analytical methods applicable to algae and algae

products used for food and feed applications.

This document does not apply to pharmaceutical, cosmetics, fertilizer/biostimulants, chemical and

biofuel applications.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN 17399, Algae and algae products - Terms and definitions
3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN 17399 and the following apply:

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1
algae and algae products

functional group of organisms consisting of microalgae, macroalgae, cyanobacteria, Labyrinthulomycetes

and products derived thereof

Note 1 to entry: examples of products are biomass, extracts or derivatives from algae, including a.o. algal oil and

algal powder.
4 Product specifications
4.1 General

The interest in algae and algae products has increased significantly in Europe as a source of

carbohydrates, proteins, lipids, minerals, several pigments etc. These materials are suitable for use in a

wide range of applications for food and feed purposes and to other sectors, such as textile, cosmetics,

biopolymers, biofuel and fertilizers and biostimulants.

Depending on the application different information on product characteristics (Clause 5) are required as

product specification by the applicable regulation.
4.2 Food

All algae and algae products intended for food or food ingredients are accompanied by basic information

on the product in line with applicable EU regulation for food labelling as well as specific directives from

some EU countries. Some are mandatory and other optional and are dependent on the target market.

These product specifications for food contain information that includes but is not limited to [27]:

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— energy;
— content of fat, saturates, carbohydrate, sugars, protein, and salt (sodium);
— other nutrients (e.g. vitamins, minerals, fibre, polyols) [31];
— total sulphites;
— moisture;
— ingredients and presence of allergens;
— shelf-life, including requirements for storage and shipping;

— contaminants as defined as critical in the risk assessment of the food safety management system (e.g.

heavy metals).
4.3 Feed

All algae and algae products intended for feed or feed ingredients are be accompanied by basic

information on the product. These product specification for feed contain information, where applicable,

that includes but is not limited to [45]:
— type of feed and intended use;
— energy;
— crude protein;
— crude oils and fats;
— crude fibre;
— crude ash;
— amino acids (lysine and methionine);
— minerals (calcium, sodium, phosphorus, magnesium);
— moisture;
— feed additives;
— minimum storage life;

— contaminants as defined as critical in the risk assessment of the feed safety management system (e.g.

heavy metals).
4.4 Type of product specification documents
4.4.1 General

Different product specification documents with information on algae and algae products should be used

by organisations. These documents are not mandatory and are used for information exchange.

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4.4.2 Technical Data Sheet (TDS)

The technical data sheet is a technical document containing the technical parameters adopted to

characterize the product and therefore being the equivalent of the Certificate of Analysis (4.3.2). The TDS

includes the typical ranges of different parameters used to define the product characteristics or

applicable regulatory limits. Examples of a TDS for some algae are attached as Annex A.

4.4.3 Certificate of Analysis (CoA)

The certificate of analysis is a document issued by the organization based on actual laboratory results to

report test results of the sample. It includes references to the analytical method and quality standard(s)

used. It may or may not have legal value.
4.4.4 Product data sheet (PDS)

The product data sheet is a document issued by the manufacturer for marketing purposes and usually

used to provide product approval information to the customer.
4.4.5 Raw Material Specification (RMS)

The raw material specification is a technical document about the product, usually prepared by

manufacturer, directed to provide all product approval information to the customer and usually attached

to a commercial contract.
4.4.6 Material Safety Data Sheet (MSDS)

The material safety data sheet is a document issued according to EC Regulation [37] with the aim of

providing product compliance information in respect of human health and safety at the workplace and

protection of the environment.

This document is issued by the manufacturer for hazardous substances and mixtures and is not required

for all materials or products. In general a MSDS is not necessary for food and feed applications.

NOTE Some customers ask for an MSDS even if it is not mandatory. It is the algae and algae product

manufacturer's responsibility to check the applicable regulation case by case. Algae and algae products may or may

not fall under the MSDS obligation.
5 Product characteristics
5.1 Purity
5.1.1 General

The product purity is defined as the percentage of a specific component in the total amount of a product.

Any other substances are specified in the technical data sheet.

Purity is affected by the accidental presence or the fraudulent addition of any organism, part or product

of an organism, other than named in the product specification and description of the concerned algae; or

any extraneous substances with the same composition as dry algae, even in the absence of contamination.

The minimum purity required for a food product will depend on the application of the algae or algae

product and is agreed with the customer. The minimum requirement of purity for feed is regulated by

legislation and customer contracts. Purity is not related to contamination since contamination will not

affect the amount of required substance.

The following substances affecting the purity of a product can be addressed [47]:

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1. Physical foreign matter (i.e. (micro) plastic fragments, wires from fishing nets and ropes, feathers

from birds, shells, etc.);

2. Other algae (including toxin‐producing cyanobacteria), bacteria or organic materials (e.g. grass,

proteins or oils from other species);

3. Algae from other origin or location than stated (i.e. from Asia instead of Europe).

NOTE 1 The percentage is specified by mass fraction (kg/kg), volume fraction (m3/m3) or cell fraction (cell

counts/all cell counts) or their corresponding concentrations if more appropriate.

NOTE 2 Foreign matter related to the use of genetically modified species or non-organic produced products are

regulated by EU Regulation.

Methods of analysis to determine the purity of algae and algae products include qualitative and

quantitative methods. If a qualitative method shows substances that affect the product purity, a

quantitative method may be necessary. Various methods are suitable for fresh materials and dry

materials or powders.

Available methods include visual inspection, microscopy, nuclear acid identification (DNA barcoding, PCR

techniques, DNA microarrays, NGS, Q-PCR), molecular and chemical fingerprinting (fatty acid profile,

pigment analysis) and isotopic analysis.
5.1.2 Physical foreign matter

Macroscopic examination is suitable for determining the presence of particles of foreign matter in whole

or cut (macro)algae. Foreign matter are all materials which are not part of the (macro)algal biomass.

Additional aids (like UV-light, sieving, centrifugation) might be helpful to find the foreign matter.

Microscopy is a suitable tool for microalgae, cyanobacteria, Labyrinthulomycetes and powdered

materials and small particles of physical foreign matter for which macroscopic examination is not

suitable. Reduction of particle size or powdering materials can hide the presence of foreign matter and

make it more difficult to detect. Also diluted samples cannot be qualified and need a quantification step.

5.1.3 Other algae, bacteria or organic materials

Visual inspection is suitable for freshly harvested macroalgae as the intact cells can be recognized as a

whole. When the holdfast is removed or when epiphytic organisms may be present on the surface and

visual inspection is not sufficient to identify the species after harvesting. Macroalgae need to be crushed

and mixed and the mixture needs to be plated to identify which colonies are present in the sample. For

ground algae, cells are disrupted and the algae species can no longer be recognized nor be

quantified. Rehydration might help here. Specifically for cyanobacteria, some guidance for the

numeration of phytoplankton can provide the degree of purity on fresh samples [1].

Macroscopical and microscopical characterization includes features, which distinguish the algae material

from potential non-specified substances. Identification tests need to be specifically validated for algae

and are usually a combination of methods depending on the algae species. Identification tests include

macroscopical characters, microscopical characters, chromatographic procedures and physicochemical

analysis. Automated tools might help like cell counters or cell flow cytometers.

The development of methods based on nuclear acids characteristics (microsatellites, NGS, barcoding,

RAPD, AFLP, etc.) to be sequenced and/or quantified (qPCR) from product samples would provide simple

and fast tools for the identification of multiple targeted species and would help to indicate the presence

of other nuclear acids than those of the algal material. Other horizontal analytical methods useful for

purity detection (molecular or chemical fingerprinting like fatty acid analysis, etc) will be developed in

CEN/TC 460 'Food and feed authenticity’. Currently, there is a lack of databases for the identification of

foreign matter.
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5.1.4 Algae from other location

The most promising test to detect the presence of algae from other regions then stated, is the use of stable

isotopes. However, first databases with the characterization of isotopes from different regions needs to

be established. Another method is the use of lipidomics tools, although these tools also require the

establishment of databases [61].

Currently these methods are not yet standardized and available for routine testing. In addition, essential

databases are not complete to identify all different species. Therefore, good farming practices (GFP), good

manufacturing practices (GMP), traceability and Chain of Custody systems are essential to monitor the

purity for algae and algae products.

An overview of the currently available types of foreign matter and respective detection methods

including qualitative and quantitative determination are shown in Annex B, Table B.1 [47]. The reliability

of these different methods depends on the complexity of the species and foreign matter and are not

necessarily sufficient for each case.
5.1.5 Methods of analysis

The inventory of available methods and recommendation for prioritizing future method development on

purity of algae and algae products are listed in Annex B, Table B.2.
Specific gaps to use these methods are lack of respectively [47]:
— sampling strategies for visual inspection and microscopy;
— quantification method for microscopy;

— databases, algae selective primers and protocols for nuclear acid identification; and

— databases for molecular and chemical fingerprinting and isotope analysis (see Annex B, Table B.3).

In addition to the gap per analysis methodology, methods are lacking for the quantification of the found

foreign matter. Furthermore, protocols describing what to do with the product if the presence of a foreign

matter is detected, are lacking.

It is recommended to further develop and standardize the following protocols [47]:

— sample strategies for quality control of fresh materials and of dry/powdered materials;

— quality control protocols describing which other checks have to be done when foreign matter is

found;

— visual inspection protocols for fresh materials and for dry/powdered materials;

— microscopical inspection protocols for fresh materials and for dry/powdered materials;

— protocol for molecular biological quality control taking into account the most important criteria;

— study the applicability of isotope analysis for specification of the region of origin.

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5.2 Contamination
5.2.1 General

A contaminant is defined as any biological or chemical agent, foreign matter, or other substances not

intentionally added to food which may compromise food safety or suitability of algae and algae products

in the food or feed application [44]. Several types of contaminants exist including chemical,

microbiological and physical contamination. Chemical contamination of algae and algae products can

occur in the open waters (macroalgae) or in a closed or semi-closed cultivation system (micro- and

macroalgae), e.g. when water sources for algae cultivation have been in contact with human or industrial

activities or outlets. Most algae tend to accumulate minerals and other compounds if present in the

surrounding environment. Therefore, this form of contamination is important to monitor. Processes to

reduce contaminants to acceptable levels are available, like rinsing.
5.2.2 Food

The contaminants for algae that have been identified as potential hazards for food safety include: heavy

metals (including uranium), toxins, pesticides, dioxins, PAH’s, allergens, pheophorbides and

microorganisms. The potential presence of these hazards depends on the algae species and its cultivation

and processing conditions.

Several gaps in legislation for macroalgae have been identified [9], [11]. Inorganic arsenic (iAs) and other

potential toxic arsenic compounds, cadmium (Cd), lead (Pb), mercury (Hg), iodine (I), selenium (Se) and

uranium (U) are of particular concern since these can be found in algae. There is a need for a clear

overview of the regulation for algae used as food. The algae market is growing and there is a need for EU

legislation on e.g. iodine and inorganic arsenic. The specific threshold values should be set by the

European Commission and EFSA (European Food Safety Authority) taking maximum levels of

...

SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 17559:2020
01-november-2020

Alge in izdelki iz alg - Uporaba hrane in krme: Splošni pregled omejitev, postopkov

in analitskih metod

Algae and algae products - Food and feed applications: General overview of limits,

procedures and analytical methods
Ta slovenski standard je istoveten z: FprCEN/TR 17559
ICS:
67.040 Živilski proizvodi na splošno Food products in general
kSIST-TP FprCEN/TR 17559:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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kSIST-TP FprCEN/TR 17559:2020
FINAL DRAFT
TECHNICAL REPORT
FprCEN/TR 17559
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2020
ICS
English Version
Algae and algae products - Food and feed applications:
General overview of limits, procedures and analytical
methods

This draft Technical Report is submitted to CEN members for Vote. It has been drawn up by the Technical Committee CEN/TC

454.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.

Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a Technical Report.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 17559:2020 E

worldwide for CEN national Members.
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kSIST-TP FprCEN/TR 17559:2020
FprCEN/TR 17559:2020 (E)
Contents Page

European foreword ...................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 6

4 Product specifications ................................................................................................................................... 6

4.1 General ............................................................................................................ Error! Bookmark not defined.

4.2 Food ..................................................................................................................................................................... 6

4.3 Feed ...................................................................................................................................................................... 7

4.4 Type of product specification documents .............................................................................................. 7

4.4.1 General ................................................................................................................................................................ 7

4.4.2 Technical Data Sheet (TDS) ......................................................................................................................... 7

4.4.3 Certificate of Analysis (CoA) ....................................................................................................................... 8

4.4.4 Product data sheet (PDS) ............................................................................................................................. 8

4.4.5 Raw Material Specification (RMS)............................................................................................................. 8

4.4.6 Material Safety Data Sheet (MSDS) ........................................................................................................... 8

5 Product characteristics ................................................................................................................................. 8

5.1 Purity ................................................................................................................................................................... 8

5.1.1 General ................................................................................................................................................................ 8

5.1.2 Physical foreign matter ................................................................................................................................ 9

5.1.3 Other algae, bacteria or organic materials ............................................................................................ 9

5.1.4 Algae from other location ............................................................................................................................ 9

5.1.5 Methods of analysis ...................................................................................................................................... 10

5.2 Contamination................................................................................................................................................ 10

5.2.1 General .............................................................................................................................................................. 10

5.2.2 Food ................................................................................................................................................................... 10

5.2.3 Feed .................................................................................................................................................................... 11

5.2.4 Common issues in food and feed for other contaminants .............................................................. 12

6 Other relevant product information ...................................................................................................... 13

6.1 Origin ................................................................................................................................................................. 13

6.1.1 General .............................................................................................................................................................. 13

6.1.2 Country of origin and place of provenance .......................................................................................... 13

6.2 Labelling ........................................................................................................................................................... 14

6.3 Verification and claims ............................................................................................................................... 14

6.4 Traceability ..................................................................................................................................................... 14

6.5 Chain of Custody ............................................................................................................................................ 14

6.6 Sustainable development ........................................................................................................................... 15

6.6.1 General .............................................................................................................................................................. 15

6.6.2 The United Nations Sustainable Development Goals ....................................................................... 15

7 Algae and algae products as Novel Food ............................................................................................... 15

7.1 Procedure ........................................................................................................................................................ 15

7.2 Methods of analysis ...................................................................................................................................... 16

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Annex A (informative) Examples of product specification documents .................................................. 17

A.1 Example Technical Data Sheet (TDS) .................................................................................................... 17

A.2 Example Certificate of Analysis (CoA) ................................................................................................... 19

Annex B (informative) Purity identification methods and gap analysis algae .................................... 21

Annex C (informative) Mapping of currently existing legislation on maximum allowed levels

of elements and other chemical contaminants in food and feed applications ....................... 24

Annex D (informative) Applicability of standards to determine the safety of novel algae and

algae food products to comply with the Novel Food Regulation (EU) No 2015/2283 ......... 27

Bibliography ................................................................................................................................................................. 35

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kSIST-TP FprCEN/TR 17559:2020
FprCEN/TR 17559:2020 (E)
European foreword

This document (FprCEN/TR 17559:2020) has been prepared by Technical Committee CEN/TC 454

“Algae and algae products”, the secretariat of which is held by NEN.
This document is currently submitted to the vote.
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Introduction

This document has been prepared by the experts of CEN/TC 454 'Algae and algae products'.

The European Committee for Standardization (CEN) was requested by the European Commission (EC) to

draft European standards or European standardization deliverables to support the implementation of

Article 3 of Directive 2009/28/EC for algae and algae-based products or intermediates.

This request, presented as Mandate M/547 , also contributes to the Communication on “Innovating for

Sustainable Growth: A Bio economy for Europe”.

The former working group CEN Technical Board Working Group 218 “Algae”, was created in 2016 to

develop a work programme as part of this Mandate. The technical committee CEN/TC 454 'Algae and

algae products' was established to carry out the work programme that will prepare a series of standards.

The interest in algae and algae-based products or intermediates has increased significantly in Europe as

a valuable source including but not limited to, carbohydrates, proteins, lipids, and several pigments.

These materials are suitable for use in a wide range of applications from food and feed purposes to other

sectors, such as textile, cosmetics, biopolymers, biofuel and fertilizer/biostimulants. Standardization was

identified as having an important role in order to promote the use of algae and algae products.

The work of CEN/TC 454 should improve the reliability of the supply chain, thereby improving the

confidence of industry and consumers in algae, which include macroalgae, microalgae, cyanobacteria,

Labyrinthulomycetes, algae-based products or intermediates and will promote and support

commercialisation of the European algae industry.

This document has been prepared in close collaboration with the CEN/TC 454 working groups. The

European standards and technical reports developed in this mandate include:
CEN/TC 454/WG 1 Terminology
- EN 17399 'Algae and algae products – Terms and Definitions'
CEN/TC 454/WG 2 Identification
- EN xxx 'Algae and algae products – Identification'
CEN/TC 454/WG 3 Productivity
- EN xxx 'Algae and algae products - Determination of productivity'
CEN/TC 454/WG 5 Specifications for non-food/feed sector applications
- CEN/TR 17611 – Specifications for cosmetics applications
- CEN/TR xxx – Specifications for chemical and biofuel applications
- CEN/TR 17612 – Specifications for pharmaceutical applications
CEN/TC 454/WG 6 Product test methods

- EN xxx 'Algae and algae products - Determination of total lipids - Ryckebosch Foubert method'

- EN 17605 'Algae and algae products - Sample treatment'
- EN xxx' Algae and algae products – Chlorophyll'

The available EU directives and other ISO and CEN standards which are of relevance for algae and algae

products for food and feed applications are listed in the bibliography.

http://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=refSearch.search

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1 Scope

This document describes product specifications, product characteristics and other relevant information

for algae and algae products for food, nutraceutical and animal feed applications. This document is a

general overview of available limits, procedures and analytical methods applicable to algae and algae

products used for food and feed applications.

This document does not apply to pharmaceutical, cosmetics, fertilizer/biostimulants, chemical and

biofuel applications.
2 Normative references
EN 17399, Algae and algae products - Terms and definitions.
3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN 17399 and the following apply:

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
algae and algae products

functional group of organisms consisting of microalgae, macroalgae, cyanobacteria, Labyrinthulomycetes

and products derived thereof

Note 1 to entry: examples of products are biomass, extracts or derivatives from algae, including a.o. algal oil and

algal powder.
4 Product specifications
4.1 General

The interest in algae and algae products has increased significantly in Europe as a source of

carbohydrates, proteins, lipids, minerals, several pigments etc. These materials are suitable for use in a

wide range of applications for food and feed purposes and to other sectors, such as textile, cosmetics,

biopolymers, biofuel and fertilizers and biostimulants.

Depending on the application different information on product characteristics (Clause 5) are required as

product specification by the applicable regulation.
4.2 Food

All algae and algae products intended for food or food ingredients are accompanied by basic information

on the product in line with applicable EU regulation for food labelling as well as specific directives from

some EU countries. Some are mandatory and other optional and are dependent on the target market.

These product specifications for food contain information that includes but is not limited to [21]:

− energy
− content of fat, saturates, carbohydrate, sugars, protein, and salt (sodium)
− other nutrients (e.g. vitamins, minerals, fibre, polyols) [26]
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− total sulphites
− moisture
− ingredients and presence of allergens
− shelf-life, including requirements for storage and shipping

− contaminants as defined as critical in the risk assessment of the food safety management system (e.g.

heavy metals)
4.3 Feed

All algae and algae products intended for feed or feed ingredients are be accompanied by basic

information on the product. These product specification for feed contain information, where applicable,

that includes but is not limited to [44]:
− type of feed and intended use
− energy
− crude protein
− crude oils and fats
− crude fibre
− crude ash
− amino acids (lysine and methionine)
− minerals (calcium, sodium, phosphorus, magnesium)
− moisture
− feed additives
− minimum storage life

− contaminants as defined as critical in the risk assessment of the feed safety management system (e.g.

heavy metals)
4.4 Type of product specification documents
4.4.1 General

Different product specification documents with information on algae and algae products should be used

by organisations. These documents are not mandatory and are used for information exchange.

4.4.2 Technical Data Sheet (TDS)

The technical data sheet is a technical document containing the technical parameters adopted to

characterize the product and therefore being the equivalent of the Certificate of Analysis (4.3.2). The TDS

includes the typical ranges of different parameters used to define the product characteristics or

applicable regulatory limits. Examples of a TDS for some algae are attached as Annex A.

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4.4.3 Certificate of Analysis (CoA)

The certificate of analysis is a document issued by the organization based on actual laboratory results to

report test results of the sample. It includes references to the analytical method and quality standard(s)

used. It may or may not have legal value.
4.4.4 Product data sheet (PDS)

The product data sheet is a document issued by the manufacturer for marketing purposes and usually

used to provide product approval information to the customer.
4.4.5 Raw Material Specification (RMS)

The raw material specification is a technical document about the product, usually prepared by

manufacturer, directed to provide all product approval information to the customer and usually attached

to a commercial contract.
4.4.6 Material Safety Data Sheet (MSDS)

The material safety data sheet is a document issued according to EC Regulation [33] with the aim of

providing product compliance information in respect of human health and safety at the workplace and

protection of the environment.

This document is issued by the manufacturer for hazardous substances and mixtures and is not required

for all materials or products. In general a MSDS is not necessary for food and feed applications.

NOTE Some customers ask for an MSDS even if it is not mandatory. It is the algae and algae product

manufacturer's responsibility to check the applicable regulation case by case. Algae and algae products may or may

not fall under the MSDS obligation.
5 Product characteristics
5.1 Purity
5.1.1 General

The product purity is defined as the percentage of a specific component in the total amount of a product.

Any other substances are specified in the technical data sheet.

Purity is affected by the accidental presence or the fraudulent addition of any organism, part or product

of an organism, other than named in the product specification and description of the concerned algae; or

any extraneous substances with the same composition as dry algae, even in the absence of contamination.

The minimum purity required for a food product will depend on the application of the algae or algae

product and is agreed with the customer. The minimum requirement of purity for feed is regulated by

legislation and customer contracts. Purity is not related to contamination since contamination will not

affect the amount of required substance.

The following substances affecting the purity of a product can be addressed [46]:

1. Physical foreign matter (i.e. (micro) plastic fragments, wires from fishing nets and ropes, feathers

from birds, shells, etc.);

2. Other algae (including toxin‐producing cyanobacteria), bacteria or organic materials (i.e. grass,

proteins or oils from other species);

3. Algae from other origin or location than stated (i.e. from Asia instead of Europe).

NOTE 1 The percentage is specified by mass fraction (kg/kg), volume fraction (m3/m3) or cell fraction (cell

counts/all cell counts) or their corresponding concentrations if more appropriate.

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NOTE 2 Foreign matter related to the use of genetically modified species or non-organic produced products are

regulated by EU Regulation.

Methods of analysis to determine the purity of algae and algae products include qualitative and

quantitative methods. If a qualitative method shows substances that affect the product purity, a

quantitative method may be necessary. Various methods are suitable for fresh materials and dry

materials or powders.

Available methods include visual inspection, microscopy, nuclear acid identification (DNA barcoding, PCR

techniques, DNA microarrays, NGS, Q-PCR), molecular and chemical fingerprinting (fatty acid profile,

pigment analysis) and isotopic analysis.
5.1.2 Physical foreign matter

Macroscopic examination is suitable for determining the presence of particles of foreign matter in whole

or cut (macro)algae. Foreign matter are all materials which are not part of the (macro)algal biomass.

Additional aids (like UV-light, sieving, centrifugation) might be helpful to find the foreign matter.

Microscopy is a suitable tool for microalgae, cyanobacteria, Labyrinthulomycetes and powdered

materials and small particles of physical foreign matter for which macroscopic examination is not

suitable. Reduction of particle size or powdering materials can hide the presence of foreign matter and

make it more difficult to detect. Also diluted samples cannot be qualified and need a quantification step.

5.1.3 Other algae, bacteria or organic materials

Visual inspection is suitable for freshly harvested macroalgae as the intact cells can be recognized as a

whole. When the holdfast is removed, epiphytic organisms may be present on the surface and visual

inspection is not sufficient to identify the species after harvesting. Macroalgae need to be crushed and

mixed and the mixture needs to be plated to identify which colonies are present in the sample. For ground

algae, cells are disrupted and the algae species can no longer be recognized nor be

quantified. Rehydration might help here. Specifically for cyanobacteria, some guidance for the

numeration of phytoplankton can provide the degree of purity on fresh samples [28].

Macroscopical and microscopical characterization includes features, which distinguish the algae material

from potential non-specified substances. Identification tests need to be specifically validated for algae

and are usually a combination of methods depending on the algae species. Identification tests include

macroscopical characters, microscopical characters, chromatographic procedures and physicochemical

analysis. Automated tools might help like cell counters or cell flow cytometers.

The development of methods based on nuclear acids characteristics (microsatellites, NGS, barcoding,

RAPD, AFLP, etc.) to be sequenced and/or quantified (qPCR) from product samples would provide simple

and fast tools for the identification of multiple targeted species and would help to indicate the presence

of other nuclear acids than those of the algal material. Other horizontal analytical methods useful for

purity detection (molecular or chemical fingerprinting like fatty acid analysis, etc) will be developed in

CEN/TC 460 'Food and feed authenticity’. Currently, there is a lack of databases for the identification of

foreign matter.
5.1.4 Algae from other location

The most promising test to detect the presence of algae from other regions then stated, is the use of stable

isotopes. However, first databases with the characterization of isotopes from different regions needs to

be established. Another method is the use of lipidomics tools, although these tools also require the

establishment of databases [60].

Currently these methods are not yet standardized and available for routine testing. In addition, essential

databases are not complete to identify all different species. Therefore, good farming practices (GFP), good

manufacturing practices (GMP), traceability and Chain of Custody systems are essential to monitor the

purity for algae and algae products.
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An overview of the currently available types of foreign matter and respective detection methods

including qualitative and quantitative determination are shown in Annex B [46]. The reliability of these

different methods depends on the complexity of the species and foreign matter and are not necessarily

sufficient for each case.
5.1.5 Methods of analysis

The inventory of available methods and recommendation for prioritizing future method development on

purity of algae and algae products are listed in Annex B.
Specific gaps to use these methods are lack of respectively [46]:
− sampling strategies for visual inspection and microscopy;
− quantification method for microscopy;

− databases, algae selective primers and protocols for nuclear acid identification, and

− databases for molecular and chemical fingerprinting and isotope analysis (see Annex B).

In addition to the gap per analysis methodology, methods are lacking for the quantification of the found

foreign matter. Furthermore, protocols describing what to do with the product if the presence of a foreign

matter is detected, are lacking.

It is recommended to further develop and standardize the following protocols [46]:

− Sample strategies for quality control of fresh materials and of dry/powdered materials;

− Quality control protocols describing which other checks have to be done when foreign matter is

found;

− Visual inspection protocols for fresh materials and for dry/powdered materials;

− Microscopical inspection protocols for fresh materials and for dry/powdered materials;

− Protocol for molecular biological quality control taking into account the most important criteria;

− Study the applicability of isotope analysis for specification of the region of origin.

5.2 Contamination
5.2.1 General

A contaminant is defined as any biological or chemical agent, foreign matter, or other substances not

intentionally added to food which may compromise food safety or suitability of algae and algae products

in the food or feed application [40]. Several types of contaminants exist including chemical,

microbiological and physical contamination. Chemical contamination of algae and algae products can

occur in the open waters (macroalgae) or in a closed or semi-closed cultivation system (micro- and

macroalgae), e.g. when water sources for algae cultivation have been in contact with human or industrial

activities or outlets. Most algae tend to accumulate minerals and other compounds if present in the

surrounding environment. Therefore, this form of contamination is important to monitor. Processes to

reduce contaminants to acceptable levels are available, like rinsing.
5.2.2 Food

The contaminants for algae that have been identified as potential hazards for food safety include: heavy

metals (including uranium), toxins, pesticides, dioxins, PAH’s, allergens, pheophorbides and

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microorganisms. The potential presence of these hazards depends on the algae species and its cultivation

and processing conditions.

Several gaps in legislation for macroalgae have been identified [3], [5]. Inorganic arsenic (iAs) and other

potential toxic arsenic compounds, cadmium (Cd), lead (Pb), mercury (Hg), iodine (I), selenium (Se) and

uranium (U) are of particular concern since these can be found in algae. There is a need for a clear

overview of the regulation for algae used as food. The algae market is growing and there is a need for EU

legislation on e.g. iodine and inorganic arsenic. The specific threshold values should be set by the

European Commission and EFSA (European Food Safety Authority) taking maximum levels of daily

intake, quantity of intake and the effects of processing into consideration.

The current available EU regulation [5] is not clear in the description whether the threshold levels are

based on dry or wet material. The threshold levels being set by EFSA should be based on dry material as

the algae or algae product. Research shows that some contaminant concentrations (e.g. iodine and

inorganic arsenic) can be decreased considerably by processing, e.g. boiling, rinsing, drying etc [62][63].

Each product has to comply with the legislation, but some national food authorities demand that the

packaging should mention specific processing to be done by the consumer before consumption. This

should be harmonized in EU legislation reg
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