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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:
1.Without prejudice to the applicable provisions of the F1... 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:
roast coffee;
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).
Textual Amendments
F1Word in Art. 1 omitted (31.12.2020) by virtue of by The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 28 (as substituted by S.I. 2020/1504, regs. 1(2), 11(9)); 2020 c. 1, Sch. 5 para. 1(1)
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.
For the purposes of this Regulation, the following definitions shall apply:
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);
‘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.
[F2“competent authority” means the central authority competent to ensure compliance with the requirements of this Regulation or any other authority to which that central authority has delegated competence;
“appropriate authority” means—
in relation to England, the Secretary of State;
in relation to Wales, the Welsh Ministers;
in relation to Scotland, the Scottish Ministers.]
Textual Amendments
F2Art. 3(3)(4) inserted (31.12.2020) by The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 29 (as amended by S.I. 2020/1504, regs. 1(2), 11(10)); 2020 c. 1, Sch. 5 para. 1(1)
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.
The benchmark levels of acrylamide presence in foodstuffs set out in Annex IV shall be reviewed by the [F3appropriate authority] 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 F4....
Textual Amendments
F3Words in Art. 5 substituted (31.12.2020) by The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 30(a); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Art. 5 omitted (31.12.2020) by virtue of The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 30(b); 2020 c. 1, Sch. 5 para. 1(1)
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.
F5...
Done at Brussels, 20 November 2017.
For the Commission
The President
Jean-Claude Juncker
Textual Amendments
F5Words in Signature omitted (31.12.2020) by virtue of The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 31; 2020 c. 1, Sch. 5 para. 1(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(8) and (EC) No 1333/2008(9) and Commission Regulation (EU) No 231/2012(10).
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.
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.
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.
Asparaginase
Acids or their salts (to reduce the level of pH of the dough)
Calcium salts.
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).U.K.
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.
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.
In the manufacturing process FBOs shall apply the following mitigation measures:
For relevant products, FBOs shall consider reducing or replacing fully or partially ammonium bicarbonate with alternative raising agents such as
sodium bicarbonate and acidulants, or
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.
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.
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.
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).
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).
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.
FBOs shall ensure that a change in products sourced from suppliers does not result in increased acrylamide levels in such cases.
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).
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:
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.
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.
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.
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.
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.
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.
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.
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.
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:
FBOs shall identify, by means of risk assessment, the critical heat-treatment step(s) in the manufacturing process that generate(s) acrylamide.
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.
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.
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.
FBOs shall have procedures in place, such as temperature controls and monitoring, to prevent the incidence of burnt products.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
FBOs shall accept products referred to in Article 1(2) only from FBOs that have implemented all mitigation measures set out in Annex I.
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.
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.
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.
Wherever possible the trueness of analysis shall be estimated by including suitable certified reference materials in the analysis.
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 |
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.
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.
Benchmark levels for the presence of acrylamide in foodstuffs referred to in Article 1(1) are as follows:
a Non-whole grain and/or non-bran based cereals. The cereal present in the largest quantity determines the category. | |
b The benchmark level to be applied to coffee substitutes from a mixture of cereals and chicory takes into account the relative proportion of these ingredients in the final product. | |
c As defined in Regulation (EU) No 609/2013. | |
Food | Benchmark level[μg/kg] |
---|---|
French fries (ready-to-eat) | 500 |
Potato crisps from fresh potatoes and from potato dough Potato-based crackers Other potato products from potato dough | 750 |
Soft bread | |
(a)Wheat based bread | 50 |
(b)Soft bread other than wheat based bread | 100 |
Breakfast cereals (excl. porridge) | |
| 300 |
| 300 |
| 150 |
Biscuits and wafers | 350 |
Crackers with the exception of potato based crackers | 400 |
Crispbread | 350 |
Ginger bread | 800 |
Products similar to the other products in this category | 300 |
Roast coffee | 400 |
Instant (soluble) coffee | 850 |
Coffee substitutes | |
(a)coffee substitutes exclusively from cereals | 500 |
(b)coffee substitutes from a mixture of cereals and chicory | b |
(c)coffee substitutes exclusively from chicory | 4 000 |
Baby foods, processed cereal based foods for infants and young children excluding biscuits and rusksc | 40 |
Biscuits and rusks for infants and young childrenc | 150 |
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).
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).
The EFSA Journal 2015;13(6):4104.
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).
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).
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).
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).
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).
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).
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).
As defined in Regulation (EU) No 609/2013.
As defined in Regulation (EU) No 609/2013.
M. Thompson et al, Pure and Applied Chemistry, 2006, 78, pp. 145-196.
Edited by M. Thompson and R. Wood, Pure and Applied Chemistry, 1995, 67, pp. 649-666.