EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11059/2016 Rev. 2 
(POOL/E2/2016/11059/11059R2 -
EN.doc) D048379/05  
[…](2017) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
establishing mitigation measures and benchmark levels for the reduction of the presence 
of acrylamide in food  
(Text with EEA relevance)   EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
establishing mitigation measures and benchmark levels for the reduction of the presence 
of acrylamide in food  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the 
Council of 29 April 2004 on the hygiene of foodstuffs1, and in particular Article 4 (4) thereof,  
Whereas:  
(1) Regulation (EC) No 852/2004 aims  to ensure a high level of consumer protectio n with 
regard to food safety. It  define s “food hygiene” as a set of measures and conditions 
necessary to control hazards and to ensure fitness for human consumption of a 
foodstuff taking into account its intended use.  Food safety hazards occur when food is 
exposed to hazardous agents which result in contamination of that f ood. Food hazards 
may be biological, chemical or physical.  
(2) Acrylamide is a contaminant as defined in Council Regulation (EEC) No 315/932 and 
as such, it  is a chemi cal hazard in the food chain.  
(3) Acrylamide is a low molecular weight, highly water soluble, org anic compound  which 
forms from the naturally occurring constituents asparagine and sugars in certain foods 
when prepared at temperatures typically higher than 120°C and low moisture.  It forms 
mainly in baked or fried carbohydrate -rich foods where raw mater ials contain its 
precursors, such as cereals, potatoes and coffee beans .  
(4) As the acrylamide levels in some foodstuffs appear to be significantly higher than the 
levels in comparable products of the same product category, a Commission 
Recommendation 2013/64 7/EU3 invited Member States' competent authorities to carry 
out investigations in the production and processing methods used by food business 
operators if the acrylamide level found in a specific foodstuff exceeded the indicative 
values set out in the Anne x to that Recommendation.  
(5) In 2015 t he Scientific Panel on Contaminants in the Food Chain (CONTAM) of the 
European Food Safety Authority ( ’the Authority ') adopted an opinion on acrylamide in 
food4. Based on animal studies, the Authority confirms previous e valuations that 
acrylamide in food potentially increases the risk of developing cancer for consumers in 
                                                 
1 OJ L 139, 30.4.2004, p. 1  
2 Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for 
contaminants in food (OJ L 37, 13.2.1993, p. 1 ). 
3 Commission Recommendatio n 2013/647/EU of 8 November 2013 on investigations into the levels of 
acrylamide in food (OJ L 301, 12.11.2013, p. 15). 
4 The EFSA Journal 2015;13(6):4104.  EN 3   EN all age groups. Since acrylamide is present in a wide range of everyday foods, this 
concern applies to all consumers but children are the most exposed a ge group on a 
body weight basis. Possible harmful effects of acrylamide on the nervous system, pre - 
and post -natal development and male reproduction were not considered to be a 
concern, based on current levels of dietary exposure . The current levels of dietary 
exposure to acrylamide across age groups indicate a concern with respect to its 
carcinogenic effects . 
(6) Given the Authority’s conclusions with respect to carcinogenic effects of acrylamide 
and in the absence of any consistent and  mandatory measures to be applied by food 
businesses in order to lower levels of acrylamide, it is necessary to ensure food safety  
and to reduce the presence of acrylamide in foodstuffs where raw materials contain its 
precursors  by laying down appropriate mitigation  measures.  The levels of acrylamide 
can be lowered by mitigation approach, such as implementation of good hygiene 
practice and application of procedures based on hazard analysis and critical control 
point (HACCP) principles . 
(7) In accordance with Article 4 of Regulation (EC) No 852/2004, food business operators 
are to follow the procedures necessary to meet targets set to achieve the object ives of 
that Regulation and to employ sampling and analysis as appropriate to maintain their 
own performance. In  that respect, the setting of targets , such as  benchmark levels,  may 
guide the implementation of hygiene rules , while ensuring the reduction of the level of 
exposure to certain hazards. Mitigation measures would  lower  the presence of 
acrylamide in food . In order to check the compliance with t he benchmark levels the 
effectiveness  of mitigation measures should be verified through sampling and analysis .  
(8) It is therefore appropriate to establish mitigation measures which identify food 
processing steps susceptib le to the formation of acrylamide in foods and set out 
activities to reduce the levels of acrylamide in those foodstuffs .  
(9) The mitigation measures set out in this Regulation are based on current scientific and 
technical knowledge  and they have proven to result in lower levels of acrylamide 
without adversely affecting the quality and microbial safety of the product. Th ose 
mitigation measures have been established following extensive consultation of 
organisations representing affected food business operator s, consumers and experts 
from competent authorities of Member States. Where the mitigation measures include 
the use of food additives and other substances, the food additives and other substances 
should be used in accordance with their authorisation of use . 
(10) Benchmark  levels are performance indicators to be used to verify the effectiveness of 
the mitigation measures and are based on experience and occurrence for broad food 
categories . They should be established at a level as low as reasonably achievable  with 
the application of all  relevant mitigation measures . The benchmark levels should be 
determined taking into account the most recent occurrence data from the Authority's 
database , whereby it is assumed that within a broad food category, the level of 
acrylam ide in 10 to 15 % of the production with the highest levels can usually be 
lowered by applying good practices.  It is acknowledged that the specified food 
categories  are in certain cases broad and that for specific foods within such a broad 
food category th ere may 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 mitigation measures. I n such situation s, the food business 
operator sho uld be able to show the evidence that he applied the relevant mitigation 
measures . EN 4   EN (11) The benchmark levels  should be regularly reviewed by the Commission with the aim 
to set lower levels, reflecting the continuous reduction of the presence of acrylamide in 
food.  
(12) Food business operators , produc ing foodstuffs within the scope of th is Regulation and 
which perform retail activities and/or directly supply only local retail establishments  
are typically small scale operators . Therefore , mitigation measures are adap ted to the 
nature of their operation . However, food business operators which are part of, or 
franchises of, a larger, interconnected operation and that are centrally supplied should  
apply additional mitigation measures practicable for larger -scale business es as th ose 
measures  further reduce t he presence of acrylamide in food and are feasible to be 
applied by such undertakings.  
(13) The effectiveness of the mitigation measures to reduce the acrylamide content should 
be verified through sampling and analysis. It i s appropriate to determine requirements 
for the sampling and analysis that has to be performed by the food business operators. 
As regards sampling, analytical requirements and frequency of sampling should be 
established in order to ensure that the obtained  analytical results are representative for 
their production. Food business operators, producing foodstuffs within the scope of 
this Regulation and which perform retail activities and/or directly supply only local 
retail establishments are exempted from the  obligation to sample and analyse their 
production  for the presence of acrylamide as such a requirement would put a 
disproportionate burden on their business.  
(14) In addition to sampling  and analysis by the business operators , Regulation (EC) No 
882/20045 requires the Member States to regularly perform official controls  to ensure 
compliance with feed and food law . The sampling and analysis performed by the 
Member States in the context of official controls should comply with the sampling 
procedures and anal ytical criteria established in application of Regulation (EC) No 
882/2004.  
(15) Complementary to the measures provided for in this Regulation, the setting of 
maximum levels for acrylamide in certain foods should be considered in accordance 
with Council Regulati on (EEC) No 315/93 following the entry into force of this 
Regulation . 
(16) The implementation of the mitigation measures by food business operators might 
involve changes to their current production process  therefore,  it is appropriate to 
provide for a transitio nal period before the measures provided for in th is Regulation 
apply.  
(17) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
                                                 
5 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on 
official controls performed to ensure the verification of compliance with feed and food law, animal 
health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).  EN 5   EN HAS ADOPTED THIS REGULATION:  
Article 1  
Scope  
1. Without prejudice to the applicable provisions of the Union law in food area, food 
business operators which produce and place on the market  foodstuffs listed in 
paragraph 2 shall in accordance with Article 2 apply the mitigation measures set out 
in Annexes I and II, in view of achieving levels of acrylamide as low as reasonably 
achievable below the benchmark levels  set out in Annex IV.   
2. Foodstuffs referred to in paragraph 1 are as follows:   
(a) French fries, other cut (deep fried) products and sliced potato crisps from fresh 
potatoes ; 
(b) potato crisps, snacks, crackers and other potato products from potato dough ; 
(c) bread; 
(d) breakfast cereals (excluding porridge) ; 
(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) ; 
(f) coffee : 
(i) roast c offee ; 
(ii) instant (soluble) coffee ; 
(g) coffee substitutes ; 
(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 Council6. 
Article 2  
Mitigation measures  
1. Food business operators, which produce and place on the market  foodstuffs listed in 
Article 1(2) shall apply  mitigation measures provided for in Annex I.  
2. By way of derogation from paragraph 1, f ood business operators  producing 
foodstuffs listed in Article 1(2) , which perform retail activities, and/or directly  
supply only local retail establishment s shall apply mitigation measures provided for 
in Part A of Annex II.  
                                                 
6 Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food 
intended for infants and young children, food for special medical purposes, and total diet replacement 
for weight control and repealing Council Directive 92 /52/EEC, Commission Directives 96/8/EC, 
1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of 
the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L  181, 
29.6.2013, p. 35) . EN 6   EN 3. Food business operators referred to in paragraph 2 which opera te 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 supplie s the f oodstuffs referred to in 
Article 1(2),  shall apply additional mitigation measures set out in Part B of Annex II.   
4. When the benchmark level s are exceeded , food business operators shall review the 
mitigation measures applied and adjust processes and controls  with the aim to 
achieve levels of acrylamide as low as reasonable achievable below the benchmark 
levels set out in Annex IV. Food business operators shall  hereby take into account 
the safety of foodstuffs , specific  production and  geographic condit ions or product 
characteristics . 
Article 3 
Definitions  
For the purposes of this Regulation, the following definitions shall apply :  
1. the definitions of 'food', 'food  business operator', 'retail' 'placing on the market'  and 
'final consumer' laid down in Articles 2 and 3 of Regulation (EC) No 178/20027. 
2. 'benchmark levels' means  performance indicators used to verify the effectiveness of 
the mitigation measures and are based on experience and occurren ce for broad food 
categories.  
Article  4 
Sampling and an alysis  
1. Food business operators  referred to in Article 2( 1) shall establish a programme for 
their own sampling and analysis of the levels of acrylamide in the food stuffs listed in 
Article 1 (2).  
2. Food business operators referred to in Article 2(1)  shall keep a record of the applied 
mitigation measures set out in Annex I .  
3. Food business operators referred to in Article 2(3) shall keep a record of the applied 
mitigation measures set out in Part A and B of Annex II. 
4. Food business operators referred to in Article 2(1)  and 2(3)  shall perform sampling 
and analysis to determine the level of acrylamide in foodstuffs in accordance with the 
requirements set out in Annex III to this Regulation and shall record the results of the 
sampling and analysis .  
5. If the sampling and analysis results indicate that the levels are not below the 
benchmark levels of acrylamide set out in Annex IV to this Regulation, food 
business operators referred to in Article 2(1)  and 2(3) shall review  without delay the 
mitigation measures in accordance with Article 2(4).  
6. By way of derogation, this Article does not apply to food business operators referred 
to in Article 2(2) . Those food business operators shall be able to provide evidence of 
the app lication of mitigation measures set ou t in part A of Annex II.  
                                                 
7 Regulation ( EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety  (OJ L 31,  1.2.2002, p. 1) . EN 7   EN Article 5 
Review of the levels of acrylamide  
The benchmark levels of acrylamide presence in foodstuffs set out in Annex IV shall be 
reviewed by the Commission  every three years and the first ti me within three years after the 
entry into application of this Regulation.  
The review of the benchmark levels shall be based on the occurrence data of acrylamide from 
the Authority's database,  related to the review period and provided to the Authority 's database 
by competent authoritie s and food business operators.  
Article 6 
Entry into force and application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply  from 4 months after the entry into force .  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER