EU Acrylamide Guidance-Doc en
EU Acrylamide Guidance-Doc en
EU Acrylamide Guidance-Doc en
IMPORTANT DISCLAIMER
“This document has no formal legal status
and, in the event of a dispute, ultimate
responsibility for the interpretation of the
law lies with the Court of Justice”
This document has been endorsed by the Standing Committee
on Plants, Animals, Food and Feed, section Novel Food and
Toxicological Safety of the Food Chain at the meeting on 11
June 2018.
This document has not been adopted by the European
Commission. Any views expressed may therefore not be
regarded as stating an official position of the Commission.
This document is an evolving document and might need to be
further updated based upon the experiences gained with the
application of Regulation (EU) 2017/2158
GUIDANCE ON THE IMPLEMENTATION OF COMMISSION
REGULATION (EU) 2017/2158 OF 20 NOVEMBER 2017
ESTABLISHING MITIGATION MEASURES AND BENCHMARK
LEVELS FOR THE REDUCTION OF THE PRESENCE OF
ACRYLAMIDE IN FOOD
A) Food products referred to in Article 1(2)
(a) French fries, other cut (deep fried) products and sliced potato crisps
from fresh potatoes;
This covers cut deep-fried and potato crisps from fresh potatoes. It includes
also deep-fried potato products to be finished in the oven.
Products such as rösti are not covered
(b) potato crisps, snacks, crackers and other potato products from
potato dough;
This covers potato crisps, potato dough based savoury snacks, potato crackers
and other potato products from potato dough.
It covers deep-fried and oven-baked products.
It covers all potato products made from potato dough;
It covers mixed doughs (mix of dough from potatoes and e.g. pulses), where
potato is the major ingredient in the dough.
Products such as pommes duchesse, croquettes, pommes noisettes,
are not covered.
(c) bread;
This covers all ordinary bakery wares which are considered bread (e.g. wheat
bread, rye bread, whole meal bread, multi grain bread, malt bread), steamed
breads and baguettes, …
The mitigation measures applicable to bread are also applicable to the
production of rolls (hamburger rolls, whole wheat rolls and milk rolls)
Products such as pita bread, Mexican tortillas, are not covered
(d) breakfast cereals (excluding porridge)
(muesli, rolled flakes and oatmeal are also excluded);
This covers all ready-to-eat breakfast cereal products. Examples include: whole
grain breakfast cereals, granola-type breakfast cereals, corn flakes, puffed
wheat or rice, multi-grain (e.g. rice, wheat and corn) breakfast cereals,
breakfast cereals made from bran, and extruded-type breakfast cereals made
from grain flour or powder.
Products such as porridge, muesli, rolled flakes (e.g. rolled oat flakes),
oatmeal, are not covered by this category
(e) fine bakery wares: cookies, biscuits, rusks, cereal bars, scones,
cornets, wafers, crumpets and gingerbread, as well as crackers, crisp
breads and bread substitutes. In this category a cracker is a dry
biscuit (a baked product based on cereal flour);
This covers sweet, salty and savoury products, such as cookies, biscuits, rusks,
cereal bars, scones, cornets, wafers, crumpets, gingerbread, as well as
unsweetened products such as crackers, crisp breads and bread substitutes
(such as breadsticks).
In this category a cracker is a dry biscuit (baked product based on cereal flour),
e.g. soda crackers, pretzel crackers, pretzel sticks, …
This category also covers pretzel crackers, rye crisps, matzo etc …
Products such as pretzel bread, doughnuts, muffins, cakes, éclairs,
croissants, rice crackers, are not covered
(f) coffee
(i) roast coffee;
Ground roasted chicory root is used as a coffee substitute product, both alone
and mixed with coffee. ‘Chicory’ means the roots of Cichorium Intybus L., not
used for the production of witloof chicory, usually used for the preparation of
beverages, suitably cleaned to be dried and roasted. ‘Chicory extract’, ‘soluble
chicory’ or ‘instant chicory’ means the concentrated product obtained by
extraction from roasted chicory using only water as the extraction medium and
excluding any process of hydrolysis involving the addition of an acid or a base.
The chicory-based dry matter content must comply with the provisions of
Directive 1999/4/EC of the European Parliament and of the Council of 22
February 1999 relating to coffee extracts and chicory extracts (OJ L 066,
13.3.1999, p.26) .
Chicory extract in solid or paste form may contain no more than 1% by weight
of substances not derived from chicory.
Liquid chicory extract may contain edible sugars, whether roasted or not, to a
proportion not exceeding 35% by weight.
There are several different types of coffee substitutes: mixture of barley, rye,
chicory, and fig; mixture of roasted barley, malted barley, chicory and rye;
mixture of roasted barley, roasted barley malt and roasted chicory; mixture of
barley, chicory, malted barley, figs, and extract of red beets; postum (made
from roasted wheat bran, wheat and molasses), malt-based flavoured drinks,
etc.
(h) baby food and, processed cereal-based food intended for infants and
young children as defined in Regulation (EU) No 609/2013 of the
European Parliament and of the Council .
‘baby food’ means food intended to fulfil the particular requirements of infants
in good health while they are being weaned, and of young children in good
health as a supplement to their diet and/or for their progressive adaptation to
ordinary food, excluding:
(i) processed cereal-based food; and
(ii) milk-based drinks and similar products intended for young children;
Retail (as defined in Regulation (EC) 178/2002): means the handling and/or
processing of food and its storage at the point of sale or delivery to the final
consumer, and includes distribution terminals, catering operations, factory
canteens, institutional catering, restaurants and other similar food service
operations, shops, supermarket distribution centres and wholesale outlets;
Final consumer (as defined in Regulation (EC) 178/2002): means the ultimate
consumer of a foodstuff who will not use the food as part of any food business
operation or activity.
Food business operators producing foodstuffs which perform only retail
activities (establishments handling and/or processing of food at the point of sale
or delivery to the final consumer) fall within this category insofar they do not
fall under the category 2(3)
1
Indicatively, food business operators who would fall within this category are those whose interests are
represented by the following European stakeholder organisation:
- FDE (FoodDrinkEurope) and relevant branch organisations:
- CAOBISCO - Association of Chocolate, Biscuit and Confectionery Industries of the European Union
- CEEREAL - European Breakfast Cereal Association
- ECF - European Coffee Federation
- ESA - European Snacks Association
- EUPPA - European Potato Processors’ Association
- FEDIMA - Federation of EU Manufacturers and Suppliers of Ingredients to the Bakery, Confectionary and
Patisserie Industries
- SNE: Specialised Nutrition Europe
-AIBI asbl: International Association of Plant Bakers
2
Indicatively, food business operators who would fall within this category are those whose interests are
represented by the following European stakeholder organisation: UEAPME (European Association of craft,
small and medium-sized enterprises), HOTREC (Umbrella association for hotels, restaurants, cafés and similar
establishments in Europe), FoodServiceEurope (European contract catering sector), Eurocommerce (retail and
wholesale sector in Europe), CEPB aisbl (European Confederation of National Bakery and Confectionary
Organisations)
Food business operators performing retail activities and directly supply local
retail establishments
Food business operators which besides performing retail activities also directly
supply only local retail establishments and food business operators which directly
supply only local retail establishments without performing retail activities fall
within this category if it concerns typically small scale operators. To determine
that these food business operators fall within this category as regards “directly
supply local retail establishments” but not category 2(1) (or 2(3)) the following
criteria can be used as guidance:
- Local: As defined at national level or according to national provisions. In case
this is not defined at national level, a distance of within 100km of the supplying
establishment could be used as indication;
- It relates to a micro-enterprise or small enterprise
(http://ec.europa.eu/growth/smes/business-friendly-environment/sme-
definition_en). In case this criterion is applied, only the personnel employed in
the production of food referred to in Article 1(2) is to be counted as regards the
number of employees;
- Other possible criteria: the ratio in turn-over between selling directly to the final
consumer and supply to other local retail establishments, occasional/seasonal
supply, the number of other local retail establishments supplied, criteria
considered relevant by the competent authority.
Retailers and wholesalers whose activities are limited to storing and delivering
products on the market (not producing food products) are not covered by the
Regulation.
Article 2(3) Food business operators producing foodstuffs listed in Article
1(2), which perform retail activities, and/or directly supply only local retail
establishments and which operate in facilities under direct control, and that
are operating under one trademark or commercial license, as a part of, or
franchise of, a larger, interconnected operation and under the instructions of
the food business operator that centrally supplies the foodstuffs3
The food business operators covered by this category are typically large,
centrally controlled (direct control) and centrally supplied chains with
standardised menus and/or same standard operating procedures in all related
decentralised facilities of the food business operator
3
Indicatively, food business operators who would fall within this category are those whose interests are
represented by the following European stakeholder organisation: Serving Europe (Branded Food and Beverage
Service Chains Association). However it is to be noted that food business operators having a large, centrally
controlled and centrally supplied chain with standardised menus and/or same standard operating procedures
in all their facilities fall within this category, independently of the organisation they are represented by.
C) Benchmark levels – definition provided in Article 3(2)
'benchmark levels' are performance indicators used to verify the effectiveness
of mitigation measures and are based on experience and occurrence for broad
food categories. The benchmark level cannot be directly used as reference to
evaluate if a product can be placed on the market or not.
When the benchmark levels are exceeded, food business operators shall
review without delay the mitigation measures applied and adjust processes
and controls with an aim to achieve levels of acrylamide as low as reasonable
achievable and below the benchmark levels set (obligations for food business
operators referred to in Article 2(1) and 2(3)). This must be demonstrated by
undertaking new representative sampling and analysis after the introduction of
additional mitigation measures.
The benchmark levels have been established for broad food categories. It is to
be acknowledged that for specific foods within such a broad food category
there could be specific production, geographic or seasonal conditions, or
product characteristics for which it is not possible to achieve the benchmark
levels despite the application of all relevant mitigation measures. In such
situations, the food business operator should be able to show evidence that
they applied the relevant mitigation measures.
Furthermore it has to be stressed that the application of mitigation measures
and benchmark levels should not result in the prohibition of certain traditional
culinary practices and/or certain traditional foods (this can include, but not
exhaustively, foods with protected designations of origin (PDOs) and protected
geographical indications (PGIs), foods traditional speciality guaranteed (TSG)).
Food business operators are obliged to apply mitigation measures and
benchmark levels with respect to culinary practices and the recipes of
traditional foods (i.e. choosing those options which result in a level of
acrylamide as low as reasonably achievable) without changing the nature and
the organoleptic characteristics of the traditional food.
Where levels of acrylamide exceed the benchmark levels, this does not
necessarily mean that the food has to be withdrawn or recalled from the
market. If considered necessary, a risk assessment has to be carried out to
determine whether the food exceeding the benchmark level has to be
withdrawn or recalled from the market in application of article 14 of the
General Food Law 178/2002.
D) Application of mitigation measures (Article 2, Annexes
I and II)
II. Dough based potato crisps, snacks, crackers and other dough based
potato products
Refers to dough based potato crisps, potato dough based savoury snacks,
potato crackers and other dough based potato products covered by Article 1 (2)
(b)
IX. Baby jar foods (low acid and prune based foods)
Refers to baby food covered by Article 1 (2) (h). It does not only include not
baby foods in jars in the strictest sense (“sensu stricto”), but also baby foods
sold in plastic pots, bags, pouches, tubes, etc.
X. Bread
Refers to products covered by Article 1 (2) (c )
d) Food business operators referred to in Article 2(2) have to apply the
mitigation measures provided for in Annex II part A
It should be noted that certain food business operators falling within Article
2(2) have no mitigation measures provided for the products
produced/processed by them in Annex II part A, e.g. food business operators
roasting coffee on a small scale and selling directly to the consumer in their
shop. Consequently, for these food business operators there is no legal
obligation to apply mitigation measures.
e) Mitigation measures to be applied by food business operator referred to in
Article 2(3)
As regards the requirement to work with calibrated fryers, equipped with
computerised timers and programmed to standard settings (time
temperature):
- Food business operators are not required to immediately purchase such
equipment provided that their current equipment is operationally fit for
purpose and well maintained.
- Food business operators may continue using standalone timers when
using fryers that are not equipped with built-in timers.
- Furthermore, as regards calibration and computerised timers, flexibility
can be applied, e.g. there is no need to have a calibration certificate
from an external body, it is sufficient to have the calibration completed
by the food business operator internally.
Frequency of sampling
Food business operators shall, undertake sampling and analysis at least
annually for products that have a known and well-controlled acrylamide level.
no seasonal variation
where there is known seasonal variation, sample(s) are expected to be
taken by the food business operator when the level of acrylamide is
expected to be the highest.
in case of changing the supply of an ingredient/raw material which is
known to influence the level of acrylamide, a representative sample
must be taken to ensure/verify that the level of acrylamide remains
below benchmark level
Food business operators shall carry out higher frequency sampling and
analysis of products having the potential to exceed the benchmark level and
shall be risk-based and consider where further mitigation measures are
feasible.
Food business operators shall specify appropriate frequencies for
analysis of each product type. If a product or process is modified in a
way that could lead to a change in the acrylamide level in the final
product an adapted frequency of sampling should be determined.
In case of exceedance of the benchmark level (corrected for recovery but not
taking into account the measurement uncertainty), food business operators
shall carry out a review of the mitigation measures applied and shall take
additional available mitigation measures to ensure that the acrylamide level in
the finished product is below the benchmark level. This must be demonstrated
by undertaking new representative sampling and analysis after the
introduction of additional mitigation measures.
For situations where no further mitigation measures are available to be applied
to further reduce the level of acrylamide, the food business operator does not
need to continue testing on a regular basis but must be able to demonstrate
that they applied all available mitigation measures to ensure the levels of
acrylamide are as low as reasonably achievable (ALARA).
For food business operators referred to in Article 2(3) it is sufficient that the
food business operators carry out tests on samples of deep fried/ oven-baked
potato products and bakery products at centralised level (not in individual
stores), whereby the food has been prepared under practical conditions
according to the standard operating procedure (SOP). This is because these
food business operators use standardised procedures for processing and
cooking products with the precise objective of serving standardised food
offerings to customers, mainly concerning deep fried/ oven-baked potato and
bakery products.
Taking into consideration the highly standardised and controlled procedures
that characterise the operations of the food business operators referred to
under Article 2(3), it is sufficient to measure the acrylamide level in samples of
deep fried/oven-baked potato products and bakery products once per year,
unless during a calendar year a key factor comes to light, that is likely to impact
the acrylamide level in relevant products (e.g. in the event that there is the
introduction of a new or adapted recipe or cooking procedure).
Business operators, who do not produce foodstuffs themselves but merely
prepare them in accordance with the manufacturer’s instructions, are not
obliged to carry out sampling and analysis themselves. In these cases:
- The manufacturer of the foodstuffs makes instruction for preparation
available to the business operator, and
- The manufacturer provides empirical evidence by means of relevant
tests that the ready-to-eat products comply with the benchmark levels if
the instruction for preparation has been followed.
Statistical correlation to be demonstrated between product attributes or
process parameters and the acrylamide level (Annex III, point 4)
A statistical correlation shows whether, and how strongly pairs of variables are
related. The number of analyses to be performed to demonstrate this
correlation depends on the variability of the analytical results. In case the
acrylamide level related to a product attribute (e.g. a specific colour) is
constant (i.e. not variable, within a small range of variation), then fewer
analyses would be sufficient to demonstrate this correlation, when compared
to the case where larger variation was observed and more analyses might be
needed.
This correlation should be demonstrated and provided by the central supplier
and does not need to be performed by the individual food business operators
who may be viewed as the end user (e.g. bake-off areas).
G) Colour guides
For food business operators referred to in Article 2(2) and 2(3), the use and
display of colour guides for the cooking of French fries and preparing toasted
sandwiches is a strong recommendation but not an obligation for the food
business operators.
For French fries: the colour guide available at http://goodfries.eu/en/home/
can be used as a reference.
light golden
Agtron = 65, USDA = 0
golden yellow
Agtron = 55, USDA = 1
golden brown
Agtron = 40, USDA = 2
For toasted sandwiches, no widely accepted and validated colour charts are
yet available.
Benchmark levels (Annex IV)
IMPORTANT REMARK: The benchmark levels have been established for
broad food categories. It is acknowledged that for specific foods within such a
broad food category there could be specific production, geographic or seasonal
conditions or product characteristics for which it is not possible to achieve the
benchmark levels, despite the application of all relevant mitigation measures. In
such situations, the food business operator should be able to show evidence
that they applied the relevant mitigation measures.
References to the scope of Article 1(2) should be read in conjunction with the
information provided in section A of this guidance document