oSIST prEN 17980:2023
(Main)Algae and algae products - Sampling - Guidelines for the definition of sampling programs and sampling protocols
Algae and algae products - Sampling - Guidelines for the definition of sampling programs and sampling protocols
This document specifies a set of principles and rules that algae producers, algae products industries, laboratories or other entities that collect algae and algae products samples can follow for the definition of their own sampling programs and sampling protocols.
In the context of this document, algae are a functional group that include microalgae, macroalgae, cyanobacteria and Labyrinthulomycetes.
As algae and their production processes are so diverse, this document does not define a specific sampling program and/or a specific sampling protocol. Instead, this document specifies the aspects that can be considered when defining one’s own sampling program and protocol.
This document describes when, where and how to draw a representative sample. For guidance on sample preparation of dry and wet samples of micro- and macroalgae, and algae products, please refer to
EN 17605.
This document is intended to be used for the collection of samples for lot characterization for commercial or legal/regulatory purposes. However, this document can also be used for any type of sampling of algae, including samples for quality control during production.
Algen und Algenprodukte - Probenahme - Leitlinien für die Festlegung von Probenahmeprogrammen und Probenahmeprotokollen
Dieses Dokument legt eine Reihe von Grundsätzen und Regeln fest, die Algenproduzenten, Industrien für Algenprodukte, Laboratorien oder andere Einrichtungen, die Proben von Algen und Algenprodukten sammeln, bei der Festlegung ihrer eigenen Probenahmeprogramme und Probenahmeprotokolle befolgen können.
Im Zusammenhang mit diesem Dokument sind Algen eine funktionelle Gruppe, die Mikroalgen, Makroalgen, Cyanobakterien und Labyrinthulomyceten umfasst.
Da Algen und ihre Produktionsprozesse so vielfältig sind, wird in diesem Dokument kein spezifisches Probenahmeprogramm und/oder spezifisches Probenahmeprotokoll festgelegt. Stattdessen werden in diesem Dokument die Aspekte aufgeführt, die bei der Festlegung eines eigenen Probenahmeprogramms und protokolls berücksichtigt werden können.
In diesem Dokument wird beschrieben, wann, wo und wie eine repräsentative Probe zu entnehmen ist. Leitlinien zur Probenvorbereitung von Trocken- und Nassproben von Mikro- und Makroalgen sowie Algenprodukten sind in EN 17605 angegeben.
Dieses Dokument ist für die Entnahme von Proben zur Charakterisierung von Partien für kommerzielle oder gesetzliche/behördliche Zwecke bestimmt. Dieses Dokument kann jedoch auch für jede Art von Probenahme von Algen verwendet werden, einschließlich Proben für die Qualitätskontrolle während der Produktion.
Algues et produits d'algues - Échantillonnage - Lignes directrices pour la définition des programmes et des protocoles d'échantillonnage
Le présent document spécifie un ensemble de principes et règles que les producteurs d’algues, transformateurs d’algues, laboratoires ou autres entités qui prélèvent des échantillons d’algues ou de produits d’algues peuvent suivre pour définir leurs propres programmes et protocoles d’échantillonnage.
Dans le contexte du présent document, les algues sont un groupe fonctionnel comprenant les microalgues, macroalgues, cyanobactéries et les Labyrinthulomycètes.
En raison de la grande diversité des algues et de leurs procédés de production, le présent document ne définit pas de programme d’échantillonnage et/ou de protocole d’échantillonnage spécifique. Il spécifie en revanche les aspects pouvant être pris en compte lors de la définition d’un programme et d’un protocole d’échantillonnage particulier.
Le présent document décrit quand, où et comment prélever un échantillon représentatif. Pour des recommandations sur la préparation des échantillons secs et humides de micro- et macroalgues et de produits d’algues, se référer à l’EN 17605.
Le présent document est destiné à être utilisé pour le prélèvement d’échantillons pour la caractérisation des lots à des fins commerciales ou légales/réglementaires. Toutefois, le présent document peut également être utilisé pour n’importe quel type d’échantillonnage d’algues, y compris les échantillons destinés au contrôle qualité pendant la production.
Alge in izdelki iz alg - Vzorčenje - Smernice za opredelitev programov in protokolov vzorčenja
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 17980:2023
01-julij-2023
Alge in izdelki iz alg - Vzorčenje - Smernice za opredelitev programov in
protokolov vzorčenja
Algae and algae products - Sampling - Guidelines for the definition of sampling programs
and sampling protocols
Algen und Algenprodukte - Probenahme - Leitlinien für die Festlegung von
Probenahmeprogrammen und Probenahmeprotokollen
Algues et produits d'algues - Échantillonnage - Lignes directrices pour la définition des
programmes et des protocoles d'échantillonnage
Ta slovenski standard je istoveten z: prEN 17980
ICS:
13.020.55 Biološki izdelki Biobased products
oSIST prEN 17980:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 17980:2023
DRAFT
EUROPEAN STANDARD
prEN 17980
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2023
ICS 13.020.55
English Version
Algae and algae products - Sampling - Guidelines for the
definition of sampling programs and sampling protocols
Algen und Algenprodukte - Probenahme - Leitlinien für
die Festlegung von Probenahmeprogrammen und
Probenahmeprotokollen
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 454.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
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, Türkiye 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 European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17980:2023 E
worldwide for CEN national Members.
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Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Principles of sampling . 7
4.1 General. 7
4.2 Basic rules to obtain a representative sample . 8
4.3 Good practices of sampling . 8
5 Development of a sampling program . 8
5.1 General. 8
5.2 Identification of a lot . 9
5.3 How to define a sample: where and when to collect, dimension and increments. 9
5.4 Number and dimension of samples if bulk material . 10
5.5 Number and dimension of samples if packaged material . 11
6 Development of a sampling protocol . 11
6.1 General. 11
6.2 Equipment . 12
6.3 Personnel . 13
6.4 Collection of increments . 13
Annex A (informative) Microalgae produced with controlled environment . 15
A.1 General information to be supplied . 15
A.2 Example of a sampling program . 15
A.3 Example of a sampling protocol . 16
Annex B (informative) Macroalgae produced/collected from the wild . 17
B.1 General information to be supplied . 17
B.2 Example of a sampling program . 17
B.3 Example of a sampling protocol . 18
Annex C (informative) Macroalgae produced in ponds/tanks with controlled environment
. 19
C.1 General information to be supplied . 19
C.2 Example of a sampling program . 19
C.3 Example of a sampling protocol . 20
Bibliography . 21
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European foreword
This document (prEN 17980:2023) 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 CEN Enquiry.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association.
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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 products.
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 products 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 and algae products and will promote and support
commercialization of the European algae industry.
This document has been developed with the aim to help algae producers and algae products industries
to establish a sound sampling program and a correct sampling protocol. The sampling program will
define the strategy for sampling, when, where and how much, and the sampling protocol will define how
the samples will be collected, packaged, labelled, preserved and transported until the final destination:
laboratory, long term storage, customer, health safety authority, etc.
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1 Scope
This document specifies a set of principles and rules that algae producers, algae products industries,
laboratories or other entities that collect algae and algae products samples can follow for the definition
of their own sampling programs and sampling protocols.
In the context of this document, algae are a functional group that include microalgae, macroalgae,
cyanobacteria and Labyrinthulomycetes.
As algae and their production processes are so diverse, this document does not define a specific sampling
program and/or a specific sampling protocol. Instead, this document specifies the aspects that can be
considered when defining one’s own sampling program and protocol.
This document describes when, where and how to draw a representative sample. For guidance on sample
preparation of dry and wet samples of micro- and macroalgae, and algae products, please refer to
EN 17605.
This document is intended to be used for the collection of samples for lot characterization for commercial
or legal/regulatory purposes. However, this document can also be used for any type of sampling of algae,
including samples for quality control during production.
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 17399:2020, Algae and algae products - Terms and definitions
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 17399:2020 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1
lot
quantity of material that is assumed to be of the same production process and represented by specified
sampling rules
[SOURCE: EN 17605:2022, 3.1]
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3.2
sample
quantity of material, from a larger amount for which the quality is to be determined
Note 1 to entry: A sample is intended to provide information on a given characteristic of the studied lot, and to form
a basis for a decision concerning the lot.
Note 2 to entry: A sample can be a laboratory sample, a test sample, a test portion, an incremental sample, or a
reserve sample.
[SOURCE: ISO 21637:2020, 3.63 — Notes to entry have been removed]
3.3
increment
incremental sample
quantity of material taken from a single place in the lot (3.1)
[SOURCE: COMMISSION REGULATION (EC) No 333/2007 of 28 March 2007]
3.4
aggregate sample
combined total of all the incremental samples (3.3) taken from the lot (3.1)
[SOURCE: COMMISSION REGULATION (EC) No 333/2007 of 28 March 2007]
3.5
representative sample
sample (3.2) in which the characteristics of the lot (3.1) from which it is drawn are maintained
Note 1 to entry: It is the case of a simple random sample where each of the items of the lot has been given the same
probability of entering the sample.
[SOURCE: CODEX ALIMENTARIUS, General Guidelines on Sampling CAC/GL 50-2004]
3.6
sampling
process of drawing or constituting a sample (3.2)
[SOURCE: ISO 21637:2020, 3.68]
3.7
sampling program
predetermined procedure for the definition of the amount, the number of increments (3.3), the timing of
the sample (3.2) and the sample collection point, to obtain representative samples (3.5)
3.8
sampling protocol
predetermined procedure for the definition of the steps to prepare, collect, package and label for
shipping, and deliver the sample (3.2) until the transfer of responsibility at final destination
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4 Principles of sampling
4.1 General
Sampling is an activity that is a common practice in almost any industrial, commercial or service area. It
is done due to economic or time constraints to characterize a collection (a lot) of heterogeneous items, as
it is not feasible to analyse the entire collection because the analysis is destructive, or too expensive.
The quality or confidence on the results of the sampling is related to two aspects: the representativeness
of the sample, and the relation between the number of items sampled and the number of items of the
entire collection.
The representativeness of the sample is based on the definition of a representative sample: the
probability of being present on the sample is the same for any item in the collection.
To ensure that this probability is verified is not a trivial issue. If the production line has in some place a
conveyor belt where the entire production passes in sequence, it is possible to ensure representativeness
if samples are collected in the entire width of the belt, and at random intervals. However, the most
common situation is the collection of samples from a pile, a tank or other three-dimensional stock of
production.
There are many aspects that can skew the results of sampling, such as;
• material segregation by size, form, density, etc.;
• production process variation due to raw material differences, parameter deviation, human error, etc.
To minimize the impact of those anomalies different strategies can be chosen, such as;
• mixing;
• agitating;
• have samples made of different increments collected in different/random periods, locations, depths,
etc.;
• take a larger sample or collect a larger number of increments to obtain a higher confidence interval.
A sampling program should define clearly the “when” to sample and “how much” sample material should
be collected. The “when” can be time or production (at which stage of production) dependent. The “how
much” should be a function of the lot size and should also be destination dependent. The “how much” may
be dependent of the confidence interval that is required for the destination.
A sampling protocol should consider 4 stages:
a) initial preparation, which defines the set of knowledge, expertise, experience needed for a correct
collection, and the safety procedures and PPE (personal protective equipment) required, and the set
of tools, packaging, labelling, preservation and transport equipment needed to be available for
collection;
b) before collection, which defines the checklist and the verification of tools, PPE, and other equipment;
c) collection, which defines the procedure of collection;
d) after collection, which defines the procedure for sample packaging, labelling, preservation, storage
and delivery to the destination, until its responsibility is transferred to other entity.
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4.2 Basic rules to obtain a representative sample
To obtain a representative sample the following rules should be in place:
a) ensure that the probability of any item being in the sample, is equal for all items: randomize the place,
time and depth of the sample collection according to the specific situation, and stick to it;
b) ensure that the items are not segregated by any means, and mix, agitate or scramble the entire
collection before sample collection if possible;
c) take as many increments as possible to complete the sample, at random locations, periods and
depths, and homogenize the collected material. If too large, this sample can be divided into
subsamples without losing representativeness;
d) if samples or increments are collected at different time intervals, be sure that they are not
synchronous with normal production cycles or other aspects of the production: avoid collection at
personnel changing, at same time in the day, etc.
4.3 Good practices of sampling
Besides specific aspects of sampling algae or algae products, there are many other aspects that are
common to sampling. This list is a reminder of those aspects that anyone collecting samples should keep
in mind for the success of their task:
a) be sure of the objective of sampling;
b) ensure that you have available all items needed to collect the sample, and following steps;
c) take all safety measures required to collect the sample;
d) ensure that the sample collected is representative of the collection;
e) take all the steps to close the container, label and preserve the sample;
f) deliver the sample as soon as possible.
It is good practice of sampling to keep a counter sample under the control for any future reference or
dispute that can arise from final destination (external lab, customer, H&S authority, etc.). This counter
sample shall be collected following the same protocol and at the same conditions (location, time and
amount) as the normal sample.
5 Development of a sampling program
5.1 General
A sampling program shall be defined based on both the internal and external context of production of
algae and algae products.
The internal context includes information on:
• production conditions, e.g. wild stock or controlled conditions;
• the production facility and unit;
• algae species;
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• lot size;
• final product.
The external context includes information on:
• the local, national or regional legal, regulatory and commercial framework;
• objective of the sampling, e.g. microbiology, contamination, physical and chemical characterization,
genetic analysis;
• final use of the sample.
When it is requested to keep a counter sample in house for future reference, then a duplicate sample shall
be collected following the protocol and at the same conditions (location, time and amount) as the normal
sample, and appropriately stored in-house.
Considering the diversity of algae production processes, the sampling program shall be defined for each
type of production unit. The sampling program shall define the amount, the number of increments, the
timing of the sample and the sample collection point, to fulfil the basic sampling principle of
representativeness.
For algae products, the production process is not so much relevant for sample collection, except what
refers to packaging: before, e.g. in bulk, or after packaging, e.g. units in warehouse. The basic sampling
principle of representativeness shall be fulfilled as well.
The lot size is relevant to determine the amount of the sample, and/or the number of increments to be
collected to obtain each sample.
Examples of a sampling program for different type of productions or collections are given in Annex A, B
and C.
5.2 Identification of a lot
For each production unit, the internally defined lot size shall be defined in terms of weight, volume or
number of packages. An example of how to physically divide into identifiable sublots is given below.
3
EXAMPLE If the lot size is larger than 1 000 kg or 1 m , it could be physically divided into identifiable sublots
3
of maximum 1 000 Kg or 1 m , s
...
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