EN Official Journal of the European Union L 304/24

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

(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 foodstuffs (1), and in particular Article 4(4) thereof,

Whereas:

(1) Regulation (EC) No 852/2004 aims to ensure a high level of consumer protection with regard to food safety. It defines ‘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 food. Food hazards may be biological, chemical or physical.

(2) Acrylamide is a contaminant as defined in Council Regulation (EEC) No 315/93 (2) and as such, it is a chemical hazard in the food chain.

(3) Acrylamide is a low molecular weight, highly water soluble, organic 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 materials 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 2013/647/EU (3) 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 Annex to that Recommendation.

(5) In 2015 the Scientific Panel on Contaminants in the Food Chain (CONTAM) of the European Food Safety Authority (‘the Authority’) adopted an opinion on acrylamide in food (4). Based on animal studies, the Authority confirms previous evaluations that acrylamide in food potentially increases the risk of developing cancer for consumers in 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 age 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 objectives 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 the 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 susceptible 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. Those mitigation measures have been established following extensive consultation of organisations representing affected food business operators, 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 acrylamide 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 there 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. In such situations, the food business operator should be able to show the evidence that he applied the relevant mitigation measures.

(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, producing foodstuffs within the scope of this Regulation and which perform retail activities and/or directly supply only local retail establishments are typically small scale operators. Therefore, mitigation measures are adapted 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 businesses as those measures further reduce the 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 is 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 882/2004 of the European Parliament and of the Council (5) 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 analytical 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 Regulation (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 transitional period before the measures provided for in this 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,

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 coffee; (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 Council (6).

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, food business operators producing foodstuffs listed in Article 1(2), which perform retail activities, and/or directly supply only local retail establishments shall apply mitigation measures provided for in Part A of Annex II.

3. Food business operators referred to in paragraph 2 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 foodstuffs referred to in Article 1(2), shall apply additional mitigation measures set out in Part B of Annex II.

4. When the benchmark levels 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 conditions 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 178/2002 of the European Parliament and of the Council (7);

(2) ‘benchmark levels’ means performance indicators used to verify the effectiveness of the mitigation measures and are based on experience and occurrence for broad food categories.

Article 4

Sampling and analysis

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 foodstuffs 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 (3) shall perform sampling and analysis to determine the level of acrylamide in foodstuffs in accordance with the requirements set out in Annex III 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, food business operators referred to in Article 2(1) and (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 application of mitigation measures set out in part A of Annex II.

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 time 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 authorities 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 11 April 2018.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 November 2017. For the Commission The President Jean-Claude JUNCKER

(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 Recommendation 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.

(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).

(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).

(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).

ANNEX I MITIGATION MEASURES REFERRED TO IN ARTICLE 2(1) Where the mitigation measures in this Annex include the use of food additives and other substances, the food additives and other substances shall be used in accordance with the provisions provided for in Regulations of the European Parliament and of the Council (EC) No 1332/2008 (1) and (EC) No 1333/2008 (2) and Commission Regulation (EU) No 231/2012 (3). I. PRODUCTS BASED ON RAW POTATOES Selection of suitable potato varieties 1. Food business operators (hereinafter ‘FBOs’) shall identify and use the potato varieties that are suitable for the product type and where the content of acrylamide precursors, such as reducing sugars (fructose and glucose) and asparagine is the lowest for the regional conditions. 2. FBOs shall use the potato varieties which have been stored in the conditions which are applicable to a specific potato variety and for the storage period determined for a specific variety. The stored potatoes shall be used within their optimal storage window. 3. FBOs shall identify potato varieties with lower acrylamide forming potential in cultivation, storage and during food processing. The results shall be documented. Acceptance criteria 1. FBOs shall specify in their arrangements regarding potato supply the maximum content of reducing sugars in potatoes and also the maximum amount of bruised, spotted or damaged potatoes. 2. If the specified content of reducing sugar content in potatoes and the amount of bruised, spotted or damaged potatoes are exceeded, FBOs may accept the potato supply by specifying additional available mitigation measures to be taken to ensure that the presence of acrylamide in the final product is as low as reasonably achievable below the benchmark level set out in Annex IV. Potato storage and transport 1. Where FBOs operate their own storage facilities: — the temperature shall be appropriate to the potato variety stored and it shall be above 6 °C; — the level of humidity shall be such as to minimise senescent sweetening; — sprouting shall be suppressed in long term stored potatoes where permitted, using appropriate agents; — during storage the level of reducing sugars in potatoes shall be tested. 2. Potato lots shall be monitored for reducing sugars at the time of harvest. 3. FBOs shall specify the potato transport conditions in terms of temperature and duration especially if outside temperatures are significantly lower than the temperature regime applied during storage, to ensure that the temperature during the transportation of potatoes is not lower than the temperature regime applied during storage. These specifications shall be documented. (a) SLICED POTATO CRISPS Recipe and process design 1. For each product design, FBOs shall specify frying oil temperatures at the exit of the fryer. Those temperatures shall be as low as feasibly possible on a specific line and for the specific product, in line with quality and food safety standards and taking into account relevant factors such as fryer manufacturer, fryer type, potato variety, total solids, potato size, growing conditions, sugar content, seasonality and the target moisture content for the product. 2. Where the frying oil temperatures at the exit of the fryer is higher than 168 °C due to a specific product, design or technology, then the FBOs shall provide data demonstrating that the level of acrylamide in the finished product is as low as reasonably achievable and that the benchmark level set out in Annex IV is achieved. 3. For each product design, FBOs shall specify the moisture content post frying which shall be set as high as feasibly possible for a specific production line and for a specific product, in accordance with expected quality and food safety standards and taking into account relevant factors such as potato variety, seasonality, tuber size, and the fryer exit temperature. The minimal moisture content shall not be lower than 1,0 %. 4. FBOs shall use in-line colour sorting (manual and/or optical-electronic) for potato crisps post frying. (b) FRENCH FRIES AND OTHER CUT DEEP FRIED OR OVEN-FRIED POTATO PRODUCTS Recipe and Process design 1. Potatoes shall be tested for reducing sugars prior to use. This can be done by fry testing using colours as an indicator of potential high reducing sugar content: indicative fry testing 20-25 centre strips, which are fried to evaluate frying colours of the potato strips against the colour specification using a USDA Munsell colour chart or calibrated company-specific charts for small operators. Alternatively the overall finished frying colour can be measured by specific equipment (e.g. Agtron). 2. FBOs shall remove immature tubers having a low underwater weight and high reducing sugar levels. The removal can be done by passing tubers through a salt brine or similar systems which make immature tubers float or by pre-washing potatoes to detect bad tubers. 3. FBOs shall remove slivers right after cutting to avoid burned pieces in the final cooked product. 4. FBOs shall blanch potato strips to remove some of the reducing sugars from the outside of the strips. 5. FBOs shall adapt blanching regimes to the specific quality attributes of the incoming raw material and they shall stay within specification limits for finished product colour. 6. FBOs shall prevent (enzymatic) discolouration and after cooking darkening of potato products. This can be done by applying disodium diphosphate (E450), which also lowers the pH level of the washing water and inhibits the browning reaction. 7. The use of reducing sugars as a browning agent shall be avoided. They may be used only if needed, to consistently stay within specification limits. FBOs shall control the colour of the final product by performing colour checks on the final cooked product. If needed after blanching, controlled addition of dextrose enables meeting the finished colour specification. Controlled addition of dextrose after blanching results in lower acrylamide levels in the final cooked product at the same colour as observed in unblanched products with only naturally accumulated reducing sugars. Information to the end users 1. For the end users, FBOs shall indicate recommended cooking methods specifying time, temperature, quantity for oven/deep fryer/pan on packaging and/or via other communication channels. For consumers the recommended cooking instructions shall be clearly displayed on all product packaging in compliance with Regulation (EU) No 1169/2011 of the European Parliament and of the Council (4) on the provision of food information to consumers. Recommended cooking methods shall be in agreement with customer specifications and requirements for professional end users and must be validated per product type to ensure products have optimal sensory quality at the lightest acceptable colour, per cooking method specified (e.g. fryer, oven) and have levels of acrylamide below the benchmark level determined in Annex IV. FBOs shall recommend to end users other than consumers that they should have tools available for the operators (e.g. chefs) to ensure good cooking methods and also provide calibrated equipment (e.g. timers, frying curves, colour grading charts (e.g. USDA/Munsell) and at minimum, clear pictures with targeted final prepared product colours. 2. FBOs shall recommend the end users in particular to: — keep the temperature between 160 and 175 °C when frying, and 180-220 °C when using an oven. Lower temperature can be used when the fan is switched on; — Preheat the cooking device (e.g. oven, air fryer) to correct temperature between 180 and 220 °C according to on-pack cooking instructions, depending on the products specifications and local requirements; — cook potatoes until a golden yellow colour; — do not overcook; — turn oven products after 10 minutes or halfway through the total cooking time; — follow the recommended cooking instructions, as provided by the manufacturer; — when preparing smaller quantities of potatoes than indicated on pack, reduce the cooking time, to avoid excessive browning of the product; — do not overfill the frying basket; fill your basket up to the halfway mark to avoid excessive oil uptake by extended frying times. II. DOUGH-BASED POTATO CRISPS, SNACKS, CRACKERS AND OTHER DOUGH-BASED POTATO PRODUCTS Raw Materials 1. For each product, FBOs shall specify target values for reducing sugars in their dehydrated potato ingredients. 2. The target value of reducing sugars in the products concerned shall be set as low as feasibly possible, taking into account all relevant factors in the design and production of the finished product such as the amount of potato ingredients in the product recipe, further possible mitigation measures, further processing of the dough, seasonality and the moisture content in the finished product. 3. Where the content of reducing sugars is higher than 1,5 % the FBOs shall provide data demonstrating that the level of acrylamide in the finished product is as low as reasonably achievable below the benchmark level set out in Annex IV. Recipe and Process Design 1. Dehydrated potato ingredients shall be analysed prior to their use either by the supplier or the user to confirm that the sugar content does not exceed the specified level. 2. Where dehydrated potato ingredients exceed the specified sugar level, FBOs shall specify the additional mitigation measures to be taken to ensure that the level of acrylamide in the final product is as low as reasonably achievable below the benchmark level set out in Annex IV. 3. For each product FBOs shall review whether it is possible to utilise the partial replacement of potato ingredients with ingredients with lower acrylamide forming potential. 4. In wet dough-based systems, FBOs shall consider the use of the following substances insofar possible, taking into account that these substances may not be synergistic in their mitigation effect i.e. specifically applies to the use of asparaginase and lowering levels of pH: — Asparaginase — Acids or their salts (to reduce the level of pH of the dough) — Calcium salts. 5. Where dough-based potato crisps, snacks or crackers are fried, FBOs shall specify frying oil temperatures for each product at the exit of the fryer, control these temperatures and maintain records to demonstrate controls. 6. The oil temperature at the fryer exit shall be as low as feasibly possible on a specific line and for the specific product, in accordance with prescribed quality and food safety standards and taking into account relevant factors, such as the fryer manufacturer, fryer type, sugar content and the target moisture content for the product. Where the temperature is higher than 175 °C at the fryer exit, FBOs shall provide data demonstrating that the level of acrylamide in the finished product. is below the benchmark level specified in Annex IV. (Note: Most pellet products are fried at temperatures higher than 175 °C because of their very short frying time and the temperatures needed to achieve the required expansion and texture of these products). 7. Where dough-based potato crisps, snacks or crackers are baked, FBOs shall specify for each product the baking temperature at the exit of the baking oven and maintain records to demonstrate controls. 8. The temperature at the exit of the baking oven/drying process shall be as low as feasibly possible on a specific line and for the specific product, in line with expected quality and food safety standards, and taking into account relevant factors such as the machinery type, reducing sugar content of the raw material and the moisture content of the product. 9. Where the product temperature is higher than 175 °C at the end of the baking/drying process, the FBOs shall provide data demonstrating that the level of acrylamide in the finished product is below the benchmark level specified in Annex IV. 10. For each product, FBOs shall specify the moisture content post frying or baking which shall be set as high as feasibly possible on a specific production line and for a specific product, in line with the product quality and food safety requirements, and taking into account the fryer exit, baking and drying temperature. The moisture content in the final product shall not be lower than 1,0 %. III. FINE BAKERY WARES The mitigation measures in this Chapter are applicable to the fine bakery wares such as cookies, biscuits, rusks, cereal bars, scones, cornets, wafers, crumpets and gingerbread, as well as unsweetened products such as crackers, crisp breads and bread substitutes. In this category a cracker is a dry biscuit (a baked product based on cereal flour), e.g. soda crackers, rye crispbreads and matzot. Agronomy In case of contract farming, where agricultural products are supplied to FBOs directly by their producers, FBOs shall ensure that the following requirements to prevent elevated asparagine levels in cereals are applied: — to follow Good Agricultural Practices on fertilisation, in particular with regard to maintaining balanced sulphur levels in the soil and to ensure a correct nitrogen application; — to follow Good Phytosanitary Practices in order to ensure the application of good practices on crop protection measures to prevent fungal infection. FBOs shall carry out controls to verify the effective application of the aforesaid requirements. Recipe and Product Design In the manufacturing process FBOs shall apply the following mitigation measures: 1. For relevant products, FBOs shall consider reducing or replacing fully or partially ammonium bicarbonate with alternative raising agents such as (a) sodium bicarbonate and acidulants, or (b) sodium bicarbonate and disodium diphosphates with organic acids or potassium variants thereof. As part of this consideration, FBOs shall ensure that the use of the said alternative raising agents do not result in organoleptic changes (taste, appearance, texture etc.) or increase the overall sodium content which influence product identity and consumers acceptance. 2. For products where the product design allows, FBOs shall replace fructose or fructose-containing ingredients such as syrups and honey with glucose or non-reducing sugars such as sucrose, particularly in recipes containing ammonium bicarbonate where possible and taking into consideration that replacing fructose or other reducing sugars may result in a modified product identity due to loss of flavour and colour formation. 3. FBOs shall use asparaginase where effective and possible to reduce asparagine and mitigate the potential for acrylamide formation. FBOs shall take into account that there is limited or no effect on the levels of acrylamide of the use of asparaginase in recipes with high fat content, low moisture or high pH value. 4. Where a product characteristic allows, FBOs shall review whether it is possible to utilise the partial replacement of wheat flour with alternative grain flour, such as rice, taking into consideration that any change will have an impact on the baking process and organoleptic properties of the products. Different types of grains have shown different levels of asparagine (typical asparagine levels are the highest in rye and in descending order lower in oats, wheat, maize and with the lowest levels in rice). 5. FBOs shall take into account in the risk assessment the impact of ingredients in the fine bakery wares that may raise acrylamide levels in the final product, and use ingredients that do not have such effects but maintain physical and organoleptic properties (such as almonds roasted at lower rather than higher temperatures and dried fruits as fructose source). 6. FBOs shall ensure that suppliers of heat treated ingredients which are susceptible to acrylamide formation carry out an acrylamide risk assessment and implement the appropriate mitigation measures. 7. FBOs shall ensure that a change in products sourced from suppliers does not result in increased acrylamide levels in such cases. 8. FBOs shall consider to add organic acids to the production process or decrease the levels of pH as far as possible and reasonable in combination with other mitigation measures and taking into account that this can result in organoleptic changes (less browning, modification of taste). Processing FBOs shall take the following mitigation measures in the manufacture of fine bakery wares and shall ensure that the measures taken are compatible with the product characteristics and food safety requirements: 1. FBO shall apply the heat input, i.e. time and temperature combination that is the most effective to reduce acrylamide formation while achieving the targeted product characteristics. 2. FBOs shall increase the moisture content in the final product in consideration of achieving the targeted product quality, the required shelf life and food safety standards. 3. Products shall be baked to a lighter colour endpoint in the final product in consideration of achieving the targeted product quality, the required shelf life and food safety standards. 4. In developing new products, FBOs shall take into account in their risk assessment the size and surface area of a particular piece of product taking into account that small product size potentially leads to higher acrylamide levels due to heat impact. 5. As certain ingredients used in the manufacture of fine bakery wares could be heat treated several times (e.g. pre-processed cereal pieces, nuts, seeds, dried fruits, etc.), which results in the raise of acrylamide levels in final products, FBOs shall adjust product and process design accordingly to comply with the benchmark levels of acrylamide set out in Annex IV. In particular the FBOs shall not use burnt products as rework. 6. For product pre-mixes that are put on the market to be baked at home or in catering establishments, FBOs shall provide preparation instructions to their customers to ensure that the acrylamide levels in the final products are as low as reasonably achievable below the benchmark levels. IV. BREAKFAST CEREALS Agronomy In case of contract farming, where agricultural products are supplied to FBOs directly by their producers, FBOs shall ensure that the following requirements to prevent elevated asparagine levels in cereals are applied: — to follow Good Agricultural Practices on fertilisation, in particular with regard to maintaining balanced sulphur levels in the soil and to ensure a correct nitrogen application; — to follow Good Phytosanitary Practices in order to ensure the application of good practices on crop protection measures to prevent fungal infection. FBOs shall carry out controls to verify the effective application of the aforesaid requirements. Recipe 1. Given that products based on maize and rice tend to have less acrylamide than those made with wheat, rye, oats and barley, FBOs shall consider using maize and rice in new product development where applicable and taking into consideration that any change will have an impact on the manufacturing process and organoleptic properties of the products. 2. FBOs shall control the addition rates at the point of addition of reducing sugars (e.g. fructose and glucose) and ingredients containing reducing sugars (e.g. honey) taking into consideration their impact on organoleptic properties and process functionalities (binding clusters for cluster formation) and which can act as precursors to acrylamide formation when added prior to heat-treatment stages. 3. FBOs shall take into account in the risk assessment the acrylamide contribution from heat-treated, dry ingredients, such as roasted and toasted nuts and oven dried fruits, and use alternative ingredients if the contribution is likely to bring the finished product above the benchmark level specified in Annex IV. 4. For heat-treated ingredients which contain 150 micrograms of acrylamide per kilogram (μg/kg) or more, FBOs shall take the following actions: — to establish a register of such ingredients; — to carry out audits of suppliers and/or analyses; — to ensure that no changes are made by the supplier of such ingredients that increase acrylamide levels. 5. When the cereal is in a flour dough format and the manufacturing process allows a sufficient time, temperature and moisture content for asparaginase to reduce asparagine levels, FBOs shall use asparaginase where required provided there is no adverse effect on flavour or risk of residual enzyme activity. Processing In the manufacture of breakfast cereals FBOs shall apply the following mitigation measures and shall ensure that the measures taken are compatible with the product characteristics and food safety requirements: 1. FBOs shall identify, by means of risk assessment, the critical heat-treatment step(s) in the manufacturing process that generate(s) acrylamide. 2. As higher heating temperatures and longer heating times generate higher acrylamide levels, FBOs shall identify an effective combination of temperature and heating times to minimise acrylamide formation without compromising the taste, texture, colour, safety and shelf-life of the product. 3. To avoid the generation of acrylamide spikes, FBOs shall control heating temperatures, times and feed-rates in order to achieve the following minimum moisture content in the final product after the final heat treatment in consideration of achieving the targeted product quality, the required shelf life and food safety standards: — toasted products: 1 g/100 g for extruded products, 1 g/100 g for batch cooked products, 2 g/100 g for steam rolled products; — direct expanded products: 0,8 g/100 g for extruded products; — baked products: 2 g/100 g for continuously cooked products; — filled products: 2 g/100 g for extruded products; — other drying: 1 g/100 g for batch cooked products, 0,8 g/100 g for gun puffed products. FBOs shall measure the moisture content and express acrylamide concentration in a dry mass to eliminate the confounding effect of moisture changes. 4. Reworking product back through the process has the potential to generate higher acrylamide levels through repeated exposure to the heat-treatments steps. FBOs therefore shall assess the impact of rework on acrylamide levels and reduce or eliminate rework. 5. FBOs shall have procedures in place, such as temperature controls and monitoring, to prevent the incidence of burnt products. V. COFFEE Recipe In considering coffee blend composition FBOs shall take into account in the risk assessment that products based on Robusta beans tend to have higher acrylamide levels than products based on Arabica beans. Processing 1. FBOs shall identify the critical roast conditions to ensure minimal acrylamide formation within the target flavour profile. 2. Control of roast conditions shall be incorporated into a Pre-requisite Program (PRP) as part of Good Manufacturing Practice (GMP). 3. FBOs shall consider the use of asparaginase treatment, insofar possible and effective to reduce the presence of acrylamide. VI. COFFEE SUBSTITUTES CONTAINING MORE THAN 50 % CEREALS Agronomy In case of contract farming, where agricultural products are supplied to FBOs directly by their producers, FBOs shall ensure that the following requirements to prevent elevated asparagine levels in cereals are applied: — to follow Good Agricultural Practices on fertilisation, in particular with regard to maintaining balanced sulphur levels in the soil and to ensure a correct nitrogen application; — to follow Good Phytosanitary Practices in order to ensure the application of good practices on crop protection measures to prevent fungal infection. FBOs shall carry out controls to verify the effective application of the aforesaid requirements. Recipe 1. Given that products based on maize and rice tend to have less acrylamide than those made with wheat, rye, oats and barley, FBOs shall consider using maize and rice in the new product development where applicable, taking into consideration that any change will have an impact on the manufacturing process and organoleptic properties of the product. 2. FBOs shall control the addition rates at the point of addition of reducing sugars (e.g. fructose and glucose) and ingredients containing reducing sugars (e.g. honey) taking into consideration the impact on organoleptic properties and process functionalities (binding clusters) and which can act as precursors to acrylamide formation when added prior to heat-treatment stages. 3. If coffee substitutes are not made exclusively from cereals, FBOs shall use of other ingredients which result in lower levels of acrylamide after high temperature processing where applicable. Processing 1. FBOs shall identify the critical roast conditions to ensure minimal acrylamide formation within the target flavour profile. 2. Control of roast conditions shall be incorporated into a Pre-requisite Program (PRP) as part of Good Manufacturing Practice (GMP). VII. COFFEE SUBSTITUTES CONTAINING MORE THAN 50 % CHICORY FBOs shall purchase only cultivars low in asparagine and FBOs shall ensure that no late and excessive nitrogen application has taken place during the growth of chicory. Recipe If coffee substitutes are not made exclusively from chicory namely, chicory content is less than 100 % and more than 50 %, FBOs shall add other ingredients, such as chicory fibres, roasted cereals, as these have been shown to be effective to reduce the acrylamide content in the final product. Processing 1. FBOs shall identify the critical roast conditions to ensure minimal acrylamide formation within the target flavour profile. Conclusions shall be documented. 2. Control of roast conditions shall be incorporated into the manufacturer's food safety management system. VIII. BABY BISCUITS AND INFANT CEREALS (5) In case of contract farming, where agricultural products are supplied to FBOs directly by their producers, FBOs shall ensure that the following requirements to prevent elevated asparagine levels in cereals are applied: — to follow Good Agricultural Practices on fertilisation, in particular with regard to maintaining balanced sulphur levels in the soil and to ensure a correct nitrogen application; — to follow Good Phytosanitary Practices in order to ensure the application of good practices on crop protection measures to prevent fungal infection. FBOs shall carry out controls to verify the effective application of the aforesaid requirements. Product Design, Processing and Heating 1. FBOs shall use asparaginase to reduce the levels of asparagine in the flour raw material insofar possible. FBOs that cannot use asparaginase due to, for example the processing requirements or product design, shall use flour raw material low in acrylamide precursors, such as fructose and glucose and asparagine. 2. FBOs shall make an assessment during recipe development that provides information on reducing sugars and asparagine, and includes options on achieving low reducing sugars in the final recipe. This need for this assessment will be dependent on use of asparaginase in the recipe. 3. FBOs shall ensure that heat treated ingredients which are susceptible to acrylamide formation are obtained from suppliers that are able to demonstrate that they have taken the appropriate mitigation measures to reduce the presence of acrylamide in those ingredients. 4. FBOs shall have a change control procedure in place to ensure that they do not make any supplier changes that increase acrylamide. 5. If the use of heat-treated raw materials and ingredients results in that in the final product the acrylamide benchmark level specified in Annex IV is exceeded, FBOs shall review the use of those products in view of achieving levels of acrylamide as low as reasonably achievable below the benchmark level set out in Annex IV. Recipe 1. Given that products based on maize and rice tend have less acrylamide than those made with wheat, rye, oats and barley, FBOs shall consider using maize and rice in new product development where applicable taking into consideration that any change will have an impact on the manufacturing process and organoleptic properties of the product. 2. FBOs shall take into account, in particular in their risk assessment, that products based on wholegrain cereals and/or with high levels of cereal bran have higher levels of acrylamide. 3. FBOs shall control the addition rates at the point of addition of reducing sugars (e.g. fructose and glucose) and ingredients containing reducing sugars (e.g. honey) taking into consideration the impact on organoleptic properties and process functionalities (binding clusters) and which can act as precursors to acrylamide formation when added prior to heat-treatment stages. 4. FBO shall determine the acrylamide contribution from heat-treated and dry ingredients, such as roasted and toasted nuts and oven dried fruits, and use alternative ingredients if the use of those ingredients brings the finished product above the benchmark level specified in Annex IV. Processing 1. FBOs shall identify, by means of risk assessment, the critical heat-treatment step(s) in the manufacturing process that generate(s) acrylamide. 2. FBOs shall measure the moisture content and express acrylamide concentration in a dry mass to eliminate the confounding effect of moisture changes. 3. FBOs shall identify and apply an effective combination of temperature and heating times to minimise acrylamide formation without compromising the taste, texture, colour, safety and shelf-life of the product. 4. FBOs shall control heating temperatures, times and feed-rates. Feed-rate and temperature control measurement systems should be calibrated regularly and these operating conditions controlled within set limits. These tasks shall be incorporated into the HACCP procedures. 5. Monitoring and controlling product moisture content after the critical heat-treatment steps has proved to be effective in controlling acrylamide levels in some processes and therefore, in these circumstances, this process can be an adequate alternative to controlling heating temperatures and times, hence shall be employed. IX. BABY JAR FOODS (LOW-ACID AND PRUNE-BASED FOODS) (6) 1. For the production of baby jar foods, FBOs shall choose raw materials with low acrylamide precursor content, e.g. reducing sugars such as fructose and glucose and asparagine. 2. In case of contract farming, where agricultural products are supplied to FBOs directly by their producers, FBOs shall ensure that the following requirements to prevent elevated asparagine levels in cereals are applied: — to follow Good Agricultural Practices on fertilisation, in particular with regard to maintaining balanced sulphur levels in the soil and to ensure a correct nitrogen application; — to follow Good Phytosanitary Practices in order to ensure the application of good practices on crop protection measures to prevent fungal infection. FBOs shall carry out controls to verify the effective application of the aforesaid requirements. 3. In prune purée purchase contracts FBOs shall include requirements which ensure that heat treatment regimes in the prune purée manufacturing process are applied that aim to reduce the occurrence of acrylamide in that product. 4. FBOs shall ensure that heat treated ingredients which are susceptible to acrylamide formation are obtained from suppliers that are able to demonstrate that they have taken the mitigation measures to reduce the presence of acrylamide in those ingredients. 5. If the use of heat-treated raw materials and ingredients results in that in the final product the benchmark level of acrylamide specified in Annex IV is exceeded, FBOs shall review the use of those materials and ingredients in view of achieving levels of acrylamide as low as reasonably achievable below the benchmark level set out in Annex IV. Recipe 1. FBOs shall take into account in the risk assessment of acrylamide in the foodstuffs concerned that products based on wholegrain cereals and/or with high levels of cereal bran have higher levels of acrylamide. 2. FBOs shall choose varieties of sweet potatoes and prunes which are as low as possible in acrylamide precursors, such as reducing sugars (e.g. fructose and glucose) and asparagine. 3. FBOs shall control the addition rates at the point of addition of reducing sugars (e.g. fructose and glucose) and ingredients containing reducing sugars (e.g. honey) added for organoleptic reasons and process functionalities (binding clusters) and which can act as precursors to acrylamide formation when added prior to heat-treatment stages. Processing 1. FBOs shall identify the key heat-treatment step(s) in the process that generate(s) the most acrylamide in order to focus further acrylamide reduction/control efforts most effectively. This has to be achieved either via a risk assessment or by directly measuring the acrylamide levels in the product before and after each heat-treatment step. 2. To avoid the generation of acrylamide spikes, FBO shall control heating temperatures, times and feed-rates. Feed-rate and temperature control measurement systems should be calibrated regularly and these operating conditions controlled within set limits. These tasks shall be incorporated into the HACCP procedures. 3. FBOs shall ensure that the lowering of thermal input to reduce acrylamide in low acid and prune based foods do not affect microbiological safety of the foodstuffs concerned. X. BREAD Agronomy In case of contract farming, where agricultural products are supplied to FBOs directly by their producers, FBOs shall ensure that the following requirements to prevent elevated asparagine levels in cereals are applied: — to follow Good Agricultural Practices on fertilisation, in particular with regard to maintaining balanced sulphur levels in the soil and to ensure a correct nitrogen application; — to follow Good Phytosanitary Practices in order to ensure the application of good practices on crop protection measures to prevent fungal infection. FBOs shall carry out controls to verify the effective application of the aforesaid requirements. Product design, processing and heating 1. FBOs shall ensure that bread is baked to a lighter colour endpoint to reduce acrylamide formation taking into account individual product design and technical possibilities. 2. FBOs shall extend the yeast fermentation time taking into account the product design and the technical possibilities. 3. FBOs shall lower thermal input by optimising baking temperature and time insofar possible. 4. FBOs shall provide baking instructions for bread that is to be finished at home, in bake-off areas, retail shops or in catering establishments. 5. FBOs shall substitute ingredients that have the potential to raise acrylamide levels in the final product where this is compatible with product design and technical possibilities, that includes for instance the use of nuts and seeds roasted at lower rather than higher temperatures. 6. FBOs shall replace fructose with glucose particularly in recipes containing ammonium bicarbonate (E503) where the product design allows and insofar possible. That includes, for instance, replacing invert sugar syrup and honey, which contain higher levels of fructose, with glucose syrup. 7. In products with low moisture content, FBOs shall use asparaginase to reduce asparagine insofar possible and taking into account product recipe, ingredients, moisture content and process. (1) Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p. 7). (2) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16). (3) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1). (4) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18). (5) As defined in Regulation (EU) No 609/2013. (6) As defined in Regulation (EU) No 609/2013.

ANNEX II PART A MITIGATION MEASURES TO BE APPLIED BY FOOD BUSINESS OPERATORS (FBOs) REFERRED TO IN ARTICLE 2(2) 1. FBOs producing potato products shall apply the following mitigation measures: — French fries and other cut (deep fried) potato products: — Potato varieties with lower sugar content shall be used, when available and insofar as compatible with the desired food product to be obtained. In this respect the provider shall be consulted for best suited potato varieties. — Potatoes shall be stored at a temperature higher than 6 °C. — Before the frying process: Except for frozen potato products for which cooking instructions shall be followed, one of the following measures shall be taken with raw French fries to reduce the sugar content, where possible and insofar as compatible with the desired food product to be obtained: — Washing and soaking preferably for 30 minutes up to 2 hours in cold water. Rinse the strips in clean water before frying. — Soaking for a few minutes in warm water. Rinse the strips in clean water before frying. — Blanching of potatoes results in lower levels of acrylamide and therefore where possible, it is appropriate to blanch potatoes. — When frying French fries or other potato products: — Frying oils and fats shall be used which allows to fry quicker and/or at lower temperatures. Cooking oil suppliers shall be consulted for the best suited oils and fats. — Frying temperatures shall be below 175 °C and in any case as low as possible taking into account the food safety requirements. — Frying oils and fats quality shall be maintained by skimming frequently to remove fines and crumbs. For the cooking of French fries, it is appropriate that the FBOs make use of available colour guides providing guidance on the optimal combination of colour and low levels of acrylamide. It is appropriate that a colour guide providing guidance on the optimal combination of colour and low levels of acrylamide is visibly displayed at the premises to the staff preparing the food. 2. FBOs producing bread and fine bakery wares shall use the following mitigation measures in the baking process: — Insofar possible and compatible with the production process and hygiene requirements: — the extension of yeast fermentation time; — the moisture content of the dough for the production of a product with low moisture content, shall be optimised; — the lowering of oven temperature and the extension cooking time. Products shall be baked to a lighter colour endpoint and dark roasting of crust shall be avoided in case the dark colour of the crust is the result of the strong roasting and not related to the specific composition or nature of the bread resulting in a dark crust. 3. When preparing sandwiches, the FBOs shall ensure that sandwiches are toasted to the optimal colour. It is appropriate that colour guides developed for specific product types, when available, providing guidance on the optimal combination of colour and low levels of acrylamide are used when producing these specific products. When using pre-packed bread or bakery products which are to be finished, cooking instructions are followed. The abovementioned colour guide providing guidance on the optimal combination of colour and low levels of acrylamide shall be visibly displayed at the premises to the staff preparing the specific food. PART B MITIGATION MEASURES TO BE APPLIED BY FOOD BUSINESS OPERATORS REFERRED TO IN ARTICLE 2(3) IN ADDITION TO THE MITIGATION MEASURES REFERRED TO IN PART A 1. General requirement FBOs shall accept products referred to in Article 1(2) only from FBOs that have implemented all mitigation measures set out in Annex I. 2. French fries and other cut (deep fried) potato products FBOs shall: — follow the instructions on storage of provided by the FBOs or the suppliers or provided for in the relevant mitigation measures in Annex I; — work with Standard Operational Procedures and calibrated fryers equipped with computerised timers and programmed to standard settings (time-temperature); — monitor the level of acrylamide in finished products to verify that the mitigation measures are effective in keeping acrylamide levels below the benchmark level. 3. Bakery products FBOs shall monitor the level of acrylamide in finished products to verify that the mitigation measures are effective in keeping acrylamide levels below the benchmark level. 4. Coffee FBOs shall ensure that the level of acrylamide in supplied coffee is lower than the benchmark level specified in Annex IV taking into account however that this may not be possible for all coffee types depending on blend and roast characteristics. In these cases a justification is provided by the supplier.

ANNEX III SAMPLING AND ANALYSIS REQUIREMENTS FOR THE MONITORING REFERRED TO IN ARTICLE 4 I. Sampling 1. The sample shall be representative for the sampled batch. 2. FBOs shall ensure that they undertake representative sampling and analysis of their products for the presence of acrylamide to verify the effectiveness of mitigation measures, i.e. the levels of acrylamide are consistently below the benchmark levels. 3. FBOs shall ensure that a representative sample of each product type is taken for analysis of acrylamide concentration. A ‘product type’ includes groups of products with the same or similar ingredients, recipe design, process design and/or process controls where these have a potential influence acrylamide levels in the finished product. Monitoring programmes shall prioritise product types that have the demonstrated potential to exceed the benchmark level and shall be risk-based where further mitigation measures are feasible. II. Analysis 1. FBOs shall provide sufficient data to enable an assessment of the level of acrylamide and of the likelihood that the product type might exceed the benchmark level. 2. The sample shall be analysed in a laboratory that participates in appropriate proficiency testing schemes (which comply with the ‘International Harmonised Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories’ (1) developed under the auspices of IUPAC/ISO/AOAC) and uses approved analytical methods for detection and quantification. Laboratories shall be able to demonstrate that they have internal quality control procedures in place. Examples of these are the ‘ISO/AOAC/IUPAC Guidelines on Internal Quality Control in Analytical Chemistry Laboratories’ (2). Wherever possible the trueness of analysis shall be estimated by including suitable certified reference materials in the analysis. 3. The method of analysis used for the analysis of acrylamide must comply with the following performance criteria Parameter Criterion Applicability Foods specified in this Regulation Specificity Free from matrix or spectral interferences Field blanks Less than Limit of Detection (LOD) Repeatability (RSDr) 0,66 times RSDR as derived from (modified) Horwitz equation Reproducibility (RSDR) as derived from (modified) Horwitz equation Recovery 75-110 % Limit of Detection (LOD) Three tenths of LOQ Limit of Quantification (LOQ) For benchmark level < 125 μg/kg: ≤ two fifths of the benchmark level (however not required to be lower than 20 μg/kg) For benchmark level ≥ 125 μg/kg: ≤ 50 μg/kg 4. Analysis of acrylamide can be replaced by measurement of product attributes (e.g. colour) or process parameters provided that a statistical correlation can be demonstrated between the product attributes or process parameters and the acrylamide level. III. Frequency of sampling 1. FBOs shall, undertake sampling and analysis at least annually for products that have a known and well-controlled acrylamide level. FBOs shall carry out higher frequency sampling and analysis of products having the potential to exceed the benchmark level and shall be risk-based where further mitigation measures are feasible. 2. Based on this assessment referred to in point II.1, the FBOs shall specify appropriate frequencies for analysis for each product type. The assessment shall be repeated if a product or process is modified in a way that could lead to a change in the acrylamide level in the final product. IV. Mitigation If the analytical result, corrected for recovery but not taking into account the measurement uncertainty, indicates that a product has exceeded the benchmark level, or contains acrylamide at a level higher than anticipated (taking into account previous analyses, but lower than the benchmark level), then the FBOs shall carry out a review of the mitigation measures applied and shall take additional available mitigation measures to ensure that acrylamide level in the finished product is below the benchmark level. This must be demonstrated by the undertaking of a new representative sampling and analysis, after the introduction of the additional mitigation measures. V. Information to competent authorities FBOs shall make the analytical results obtained from the analysis every year available on request to the competent authority together with descriptions of the products analysed. Details of mitigation measures taken to reduce levels of acrylamide below the benchmark level shall be provided for those products exceeding the benchmark level. (1) M. Thompson et al, Pure and Applied Chemistry, 2006, 78, pp. 145-196. (2) Edited by M. Thompson and R. Wood, Pure and Applied Chemistry, 1995, 67, pp. 649-666.