Directorate-General for Health & Food Safety EU policy on acrylamide in food reducing human exposure to ensure a high level of human health protection Frans Verstraete
Principles for regulating contaminants in food in the EU * a high level of protection of human health has to be pursued * free movement within the European Union of food compliant with EU legislation * international standards to be taken into account. * food placed on the market shall be safe * contaminant levels shall be kept as low as can reasonably be achieved following good practices at all stages (ALARA) 2
Principles for regulating contaminants in food in the EU In order to achieve the general objective of a high level of protection of human health and animal health, EU feed and food legislation shall be based on risk analysis (process consisting of three interconnected components: risk assessmentrisk management-risk communication) Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner Risk management shall take into account the results of risk assessment, other factors legitimate to the matter under consideration and the precautionary principle where appropriate 3
From risk assessment to risk management Scientific risk assessment: assessment of the risks related to the presence of a contaminant in foodstuffs for human health / establishment of a tolerable intake / health based guidance value exposure assessment: human exposure (average and 95 percentile) Particular attention to vulnerable groups of population, high level consumers,... risk characterisation: human exposure assessed in relation to the health based guidance value ----> is the basis for the management measures to be taken 4
From risk assessment to risk management Risk assessment : health based guidance value new approaches (The Margin of Exposure (MOE) approach, threshold of toxicological concern (TTC) ) Risk assessment is always the basis for taking risk management measures related to food safety/ presence of contaminants in food. 5
Other legitimate factors as regards contaminants in food Other legitimate factors: considered on a case by case basis Cost benefit considerations Balance risks of contaminants benefits of consumption of certain foods (health risk health benefit considerations) Feasibility/achievability by applying good practices Analytical achievability/feasibility Efficiency of the envisaged management measures 6
Types of contaminants Agricultural contaminants Nitrates, mycotoxins, inherent plant toxins, Environmental and industrial contaminants heavy metals (mercury, lead, cadmium, etc.), dioxins, PCBs, Process related contaminants acrylamide, furans, PAHs,..
EFSA opinion June 2015 EFSA confirms that acrylamide is a carcinogenic substance and that current levels of dietary exposure to acrylamide indicate a concern with respect to the carcinogenic effects. EFSA stated that the levels of acrylamide were not consistently decreased in recent years. The main contributors to the exposure are potato-based products, cereal based products and coffee (and coffee substitutes).
Investigations Member States following Commission Recommendations The investigations performed by the Member States in application of Commission Recommendations (early 2011 replaced by Commission Recommendation 2013/647/EU of 8 November 2013), showed that the implementation by food business operators of mitigation measures to reduce the presence of acrylamide were very variable from no measures taken at all to correct application of mitigation measures.
Discussion on further regulatory measures following EFSA opinion It is of major importance to reduce the presence of acrylamide in food to ensure a high level of human health protection. Regulatory measures have to be enforceable, feasible and credible for an effective reduction of the presence of acrylamide in food.
The envisaged regulatory measure The regulatory measure is based upon the Food Hygiene Regulation. The objective of the Food Hygiene Regulation is to ensure a high level of consumer protection with regard to food safety, including chemical hazards, through the application of food safety management measures to be applied by food business operators. Imposing of mandatory application by all concerned food business operators of mitigation measures to reduce the presence acrylamide in food. These mitigation measures contain clear obligations for the food business operators and are integrated in the envisaged regulatory measure. The mitigation measures to be applied take into account the size and the nature of establishment, with the clear objective to achieve a reduction by setting strict levels to be used as a benchmark.
The envisaged regulatory measure Benchmark levels reflect the level which can be achieved on a consistent basis by applying mitigation measures to reduce the presence of acrylamide as low as reasonably achievable. The benchmark levels to be used to measure the efficacy of the applied mitigation measures are be set at a strict level taking into account the most recent occurrence data from the EFSA database. Food business operators are obliged to monitor the effectiveness of the mitigation measures to reduce the presence of acrylamide by sampling and analysis of their production demonstrating that the levels of acrylamide are below the set benchmark levels
The envisaged regulatory measure Furthermore, provisions are foreseen to ensure effective enforcement by national authorities and evidence to be provided that the levels of acrylamide are effectively reduced.
Next regulatory steps Complementary to the regulatory measure obliging food business operators to apply mitigation measures, it is foreseen in a second phase to initiate the discussion on setting maximum levels for acrylamide in certain foods or food categories which are placed on the market ready to eat immediately after the adoption of the regulatory measure obliging food business operators to apply mitigation measures
Raising awareness In addition to any regulatory measures, it is also important to raise awareness amongst consumers as a significant part of the exposure to acrylamide may come from homecooking. The Commission envisages to launch awareness campaigns targeted to consumers in co-operation with Member States and consumer organisations Given that the envisaged regulatory measure shall affect many food business operators, it is appropriate to inform the food business operators of the importance of reducing acrylamide and the obligation to comply with the envisaged regulatory measures. The Commission envisages to launch information campaigns targeted to food business operators in co-operation with Member States and relevant stakeholder organisations.
Why envisaged regulatory approach? Mandatory application of mitigation measures to reduce acrylamide by all concerned food business operators. This means that food business operators would be obliged to apply new mitigation measures which have been proven to reduce the presence of acrylamide. Regularly review the benchmark levels of acrylamide in food at regular intervals, with the aim to lowering them in the future. Envisaged approach shall ensure that food business operators have continuously to apply mitigation measures to achieve levels of acrylamide as low as reasonably achievable, therefore levels of acrylamide in food are continuously reduced by the application of mitigation measures including new developments.
Why not maximum levels now? In the case of acrylamide, the setting of maximum levels is not straightforward. As an example, levels of acrylamide in crisps or French fries produced from potatoes which have been stored over the winter are much higher than in crisps or French fries produced from freshly harvested potatoes (as reducing sugars - precursor of acrylamide - are accumulating in potatoes during storage). Furthermore there are mitigation measures which reduce the presence of acrylamide, such as the use of asparaginase, which cannot be used in organic production.
Why not maximum levels now? Within a product category there are specific niche/traditional products which have higher levels of acrylamide because the ingredients used for these niche/traditional products contain more asparagine and/or sugars than the other products of the same food category setting a maximum level without taking this into account would have as result that these traditional/niche products can no longer be produced and placed on the market. For certain foods or food categories, which are placed on the market ready-to-eat, it is foreseen to initiate the discussion on setting maximum levels, after the adoption of and complementary to the envisaged measures The maximum levels shall be set to achieve a high level of public health protection but also a careful assessment of the potential consequences of the setting of a maximum level for certain niche/traditional products or production chains shall be necessary.
Are controls delegated to food business operators? This is not true Food business operators will maintain a different and separate role from that of the competent authorities of the Member States. Food business operators will be required to perform controls to verify the effectiveness of their mitigation measures to reduce the presence of acrylamide and to take if necessary remediation measures. The responsibility for controls on acrylamide is with the competent authorities of the Member States, which will have to take sufficient samples of food on the market. In case they find levels of above the benchmark level, food business operator in question can be inspected to control (1) if the appropriate mitigation measures have been applied, (2) if the operator has performed sufficient controls to check the effectiveness of the mitigation measures and (3) if the operator has taken the necessary measures to remediate the situation
Final remarks There is a need to take regulatory measures to reduce the presence of acrylamide in food without further delay The envisaged measures shall result in an effective reduction of the presence of acrylamide in food. With the adoption of the envisaged regulatory measures on acrylamide in food, the EU shall have the strictest regulation worldwide as regards presence of acrylamide in food. In addition to the regulatory measures, it is also important to raise awareness amongst consumers as a significant part of the exposure to acrylamide may come from home-cooking.
Thank you for your attention! 21