This assigns primary legal responsibility for the safety of the products placed on the market to business operators. It provides the criteria to take into account when undertaking work to establish the safe use of botanicals or derived preparations. EFSA’s work in this field aims to provide any organisation assessing the safety of botanical ingredients with a science-based approach. While most of these products have a long history of use in Europe, some concerns exist about their safety and quality. When you submit an application, you will find it useful to understand the jargon used to explain certain procedural aspects. What happens after I’ve submitted a valid application? Monitor progress & provide additional information if requested. If your application has all the necessary information, the assessment should take up to 9 months. It is also visible on our Open.EFSA Portal, a publicly available platform where users can follow the life cycle of all our ongoing and completed risk assessments. Once you have created your application and uploaded all the required information and documents in the ESFC e-submission system, your application is ready for submission. You need to register on our platform to access our support and start getting ready to submit your application. In addition, it needs to contain data on the bioavailability of the nutrient from the source. Because of their particular physiological status, pregnant and lactating women are specific target populations and the proposed uses and use levels that you provide. They work based on the information on the target population Section of the healthy population defined by a specified age range and gender. You need to register on another platform to prepare your application for submission. From the early stages of your application, we strongly recommend requesting pre-submission advice to clarify any doubts you may have regarding the requirements and content of your future application. Legislation The use of ingredients other than vitamins and minerals (e.g. botanicals) in the manufacture of food supplements may also be authorised under other specific legislations depending on the nature of the substance (e.g. novel foods, substances for the fortification of food, foods for specific groups). Between 2005 and 2009, EFSA carried out a comprehensive assessment of substances that are permitted to be used as sources of vitamins and minerals in food supplements in the EU. The activities of EFSA in establishing tolerable upper intake levels (ULs) of individual micronutrients for different population groups provide support to the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods. Harmonised legislation regulates the vitamins and minerals, and the substances used as their sources, which can be used in the manufacturing of food supplements. This includes the safety assessment of active substances in certain botanicals used in foods such as plant preparations. As such, it is a tool for scientific assessors at EFSA and in EU Member States, for risk managers at EU and national level, and for applicants/manufacturers in areas such as food supplements, novel food Foodstuff or food ingredient that was not used for human consumption to a significant degree within the European Union before 15 May 1997, and feed additives.A wide range of nutrients and other ingredients might be present in food supplements, including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts.A draft of the updated Guidance is now available for feedback - if you are a nutrition expert, scientist or have scientific information to share, we want to hear from you during our public consultation!Responsibility for the safety of these products lies with the food business operator placing the product on the market.Companies wishing to market a nutrient source not included in the permitted list have to submit an application to the European Commission.There is one scientific guidance document that will help you prepare your applications for a nutrient source.It provides the criteria to take into account when undertaking work to establish the safe use of botanicals or derived preparations. Safety of glucosyl hesperidin as a Novel food pursuant to Regulation (EU) 2015/2283 The assessment included both the evaluation of the safety of a nutrient source at the intake levels suggested by the applicant, and the bioavailability A term to describe how much of a substance gets into the blood through a variety of routes, including the diet. Guidance documents are used by applicants when submitting scientific information in applications for market authorisation and by risk assessors during the evaluation process. A wide range of nutrients and other ingredients might be present in food supplements, including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts. Most vitamins are 'essential' as they are not made within the body or a mineral A naturally occurring inorganic element (e.g. calcium, iron) that is needed in the diet for normal growth, development and health that is added to foods or used in the manufacture of foods. It is not the role of EFSA or EMA to determine the classification of a botanical as a medicine or a food supplement Foodstuff containing concentrated amounts of nutrients or other substances that are intended to supplement the normal diet. Safety of Clostridium butyricum TO‐A as a novel food pursuant to Regulation (EU) 2015/2283 N.B. We regularly update our administrative guidance documents to take account of new working practices. Consult this page for information on how to request confidentiality for specific information in your application. Please be aware that we are required by law to make the non-confidential version of your application publicly available in the course of the application process and to hold a public consultation. You need to use different documents and tools during each phase to move the process forward. Below you can follow our step-by-step guide to the application process. In addition, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties. Due to the complex nature of the issue and the divergent views expressed by the parties involved, this process is ongoing and no final conclusion has been reached. Member States may, for monitoring purposes, request notification of the placing on the market in their territory of a food supplement. A draft of the updated Guidance is now available for feedback - if you are a nutrition expert, scientist or have scientific information to share, we want to hear from you during our public consultation! Please refer to the scientific guidance documents when using these tools. Please keep in mind that you need to use only one of the two tools when preparing an application for authorisation of a nutrient source. The Food Additives Intake Model (FAIM) helps you to calculate the maximum levels (concentrations) of anticipated and combined intake, and to estimate the consumer exposure to substances of safety concern. N.B. We sometimes update our scientific guidance documents to take account of new science, tools and working practices. They specify the administrative requirements for preparing and submitting an application and provide practical tips and tools to support this process. Botanicals Please keep in mind that you need to use only one of the two tools when preparing an application for authorisation of a nutrient source.The database is not intended to conclude on the safety or non-safety of the listed plant species, but to help with the safety assessment of botanicals and botanical preparations by facilitating hazard identification The first step in risk assessment, this involves the identification of biological, chemical, and physical agents capable of causing adverse health effects.Please be aware that we are required by law to make the non-confidential version of your application publicly available in the course of the application process and to hold a public consultation.You can monitor the progress of your application using the ESFC.The Commission, together with EU Member States, decides whether to authorise your nutrient source and for what purpose.When the completeness check is over, we proceed with the validation of the application.The presence of a substance of concern in a botanical A substance, used either as a food or a medicine, derived from plants, fungi, algae or lichens does not necessarily mean that the substance poses a risk to consumer health. Publication follows adoption but usually takes a few weeks as we carry out editorial checks and adapt the document to the scientific publishing platform used for the EFSA Journal. This can happen for different reasons, for example, the studies provided did not allow a clear-cut conclusion about a possible health effect, or the quality of the studies may not have been high enough for the results to be considered reliable. You can monitor the progress of your application using the ESFC. During this phase, we hold a public consultation on the non-confidential version of the application dossier through Connect.EFSA. After the application is validated, our scientists will assess your application. There are at present no binding maximum and minimum levels for the ingredients of food supplements defined in the European Union. Because food supplements are considered as food, it is the responsibility of the manufacturer, importer, supplier or distributor to ensure that a food supplement placed on the market is safe. Finally, as with all the other food products, food supplements may contain additives (e.g. sweeteners, colours, coating agents). EFSA provides scientific opinions to support the evaluations carried out by the European Commission. Responsibility for the safety of these products lies with the food business operator placing the product on the market. The directive lays down the rules applicable only to the use of vitamins and minerals in the manufacture of food supplements.Consult this page for information on how to request confidentiality for specific information in your application.It may refer to vitamins, additives, pesticides or medicines of the nutrient from the source i.e. the effectiveness with which the mineral or vitamin is released into the body.The Food Additives Intake Model (FAIM) helps you to calculate the maximum levels (concentrations) of anticipated and combined intake, and to estimate the consumer exposure to substances of safety concern.Below you can follow our step-by-step guide to the application process.Please check that you use the latest version of these documents before applying!In addition, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.Moreover, EFSA has performed a comprehensive evaluation of the possible adverse health effects of individual micronutrients at intakes exceeding the dietary requirements and, where possible, established tolerable upper intake levels (ULs) for different population groups. It may refer to vitamins, additives, pesticides or medicines of the nutrient from the source i.e. the effectiveness with which the mineral or vitamin is released into the body. The EU does not have a centralised authorisation procedure for the use of botanicals and derived preparations in food. Botanicals and derived preparations made from plants, algae, fungi or lichens have become widely available on the EU market in the form of food supplements. The Commission, together with EU Member States, decides whether to authorise your nutrient source and for what purpose. Once the scientific opinion is adopted, responsibility for your application switches from EFSA to the European Commission. The use of substances other than vitamins or minerals in the manufacture of food supplements may be governed by national rules or may be subject to other specific EU legislation. Throughout this work EFSA provides support to the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods. For ingredients other than vitamins and minerals, the European Commission has established harmonised rules to protect consumers against potential health risks and maintains a list of substances which are known or suspected to have adverse effects on health and the use of which is therefore controlled. The authorisation and monitoring of botanicals use in food and food supplements are a national competency of EU Member States. This work was initiated in 2004 when the members of EFSA’s Advisory Forum underlined the need for science-based guidance for assessing the safety of botanicals. Among the new features the Compendium now boasts an extensive list of 1,538 naturally occurring substances of potential concern for human health. These include the risk of chemical or microbiological contamination and the need to ensure that concentrations of active substances are within safe limits. Such products are typically labelled as natural foods and a variety of claims are made regarding their possible health benefits. Please check that you use the latest version of these documents before applying! For any question on the authorisation and the legislation, contact the sante-consult-e1 at ec.europa.eu (European Commission). EU legislation explains the overall process, the steps in the authorisation procedure, and subsequent marketing of the product. This diagram gives you an overview of the process and indicates the tools you need to use at each stage. When the completeness check is over, we proceed with the validation of the application. Once you’ve submitted your application, at EFSA we do a completeness check. The second tool, Dietary Exposure (DietEx), uses the same food consumption data as FAIM, but the information is categorised according to EFSA’s FoodEx2 food classification system. Most vitamins are 'essential' as they are not made within the body or a mineral A naturally occurring inorganic element (e.g. calcium, iron) that is needed in the diet for normal growth, development and health that is added to foods or used in the manufacture of foods.They specify the administrative requirements for preparing and submitting an application and provide practical tips and tools to support this process.This work was initiated in 2004 when the members of EFSA’s Advisory Forum underlined the need for science-based guidance for assessing the safety of botanicals.This may happen when the addition of a substance in food products increases its exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time to levels greatly exceeding the normal consumption and/or poses a potential risk to consumers.Substances not falling in the above categories may still be found in food supplements present on national markets subject to provisions in the specific national legislations.The activities of EFSA in establishing tolerable upper intake levels (ULs) of individual micronutrients for different population groups provide support to the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods.The European Medicines Agency (EMA) is responsible for assessing both the safety and efficacy How well something works in relation to predefined standards or expectations of herbal preparations when used as medicines.The second tool, Dietary Exposure (DietEx), uses the same food consumption data as FAIM, but the information is categorised according to EFSA’s FoodEx2 food classification system.For any question on the authorisation and the legislation, contact the sante-consult-e1 at ec.europa.eu (European Commission). In 2009 EFSA published a toolkit to help assess the safety of botanicals and derived preparations which are intended for use in food supplements. As such, it is a tool for scientific assessors at EFSA and in EU Member States, for risk managers at EU and national level, and for applicants/manufacturers in areas such as food supplements, novel food Foodstuff or food ingredient that was not used for human consumption to a significant degree within the European Union before 15 May 1997, and feed additives. The presence of a substance of concern in a botanical A substance, used either as a food or a medicine, derived from plants, fungi, algae or lichens does not necessarily mean that the substance poses a risk to consumer health. Safety assessments of botanicals EFSA’s administrative guidance documents describe in detail all the different phases of the application life-cycle, from pre-submission to the conclusion of the evaluation. At EFSA we assess the safety of any new nutrient An element or compound needed for normal growth, development and health maintenance. Substances not falling in the above categories may still be found in food supplements present on national markets subject to provisions in the specific national legislations. ULs represent the highest level of chronic daily intake of a nutrient that is not likely to pose a risk of adverse health effects to humans. Companies wishing to market a nutrient source not included in the permitted list have to submit an application to the European Commission. There is one scientific guidance document that will help you prepare your applications for a nutrient source. The European Commission, on its own initiative or on the basis of information provided by the Member States and following an assessment by EFSA, may take a decision to include a certain substance in a list of substances whose use in foods is prohibited, restricted or under scrutiny. The directive lays down the rules applicable only to the use of vitamins and minerals in the manufacture of food supplements. The ULs defined by EFSA and by the former Scientific Committee on Food (SCF) are used as a reference in EFSA’s evaluations of the safety of nutrient sources added to food supplements. Below you can follow our step-by-step guide to the application process.The use of substances other than vitamins or minerals in the manufacture of food supplements may be governed by national rules or may be subject to other specific EU legislation.In addition, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.The directive lays down the rules applicable only to the use of vitamins and minerals in the manufacture of food supplements.It may refer to vitamins, additives, pesticides or medicines of the nutrient from the source i.e. the effectiveness with which the mineral or vitamin is released into the body.Moreover, EFSA has performed a comprehensive evaluation of the possible adverse health effects of individual micronutrients at intakes exceeding the dietary requirements and, where possible, established tolerable upper intake levels (ULs) for different population groups.You need to register on another platform to prepare your application for submission.Please check that you use the latest version of these documents before applying! Nutrient source application procedure Scientific guidance documents tell you what scientific data and other information you need to include in your nutrient source application dossier. Annex II of the same directive contains a list of substances that are authorised as source of the vitamins and minerals listed in Annex I (e.g. sodium-L-ascorbate as a source of vitamin C, calcium lactate as a source of calcium). The toolkit is intended for both risk assessors who want to consider the safety of a given botanical ingredient Any substance deliberately added to a foodstuff which will remain in the finished product, even in an altered form, and food manufacturers who are responsible for ensuring that the products they put on the market are safe. The database is not intended to conclude on the safety or non-safety of the listed plant species, but to help with the safety assessment of botanicals and botanical preparations by facilitating hazard identification The first step in risk assessment, this involves the identification of biological, chemical, and physical agents capable of causing adverse health effects. Moreover, EFSA has performed a comprehensive evaluation of the possible adverse health effects of individual micronutrients at intakes exceeding the dietary requirements and, where possible, established tolerable upper intake levels (ULs) for different population groups. We regularly update these documents to take account of the latest science and recent experience in the evaluation of applications. The European Medicines Agency (EMA) is responsible for assessing both the safety and efficacy How well something works in relation to predefined standards or expectations of herbal preparations when used as medicines. Botanicals and derived preparations made from plants, algae, fungi or lichens have become widely available on the EU market in the form of food supplements.Guidance documents are used by applicants when submitting scientific information in applications for market authorisation and by risk assessors during the evaluation process.From the early stages of your application, we strongly recommend requesting pre-submission advice to clarify any doubts you may have regarding the requirements and content of your future application.After the application is validated, our scientists will assess your application.Based on EFSA’s work, the European Commission reviews and updates the list of vitamin or mineral substances that may be used in food supplements.Depending on national legislation in place, some botanicals are considered traditional herbal medicinal plants or food supplements.The use of ingredients other than vitamins and minerals (e.g. botanicals) in the manufacture of food supplements may also be authorised under other specific legislations depending on the nature of the substance (e.g. novel foods, substances for the fortification of food, foods for specific groups).Because of their particular physiological status, pregnant and lactating women are specific target populations and the proposed uses and use levels that you provide.Once you have created your application and uploaded all the required information and documents in the ESFC e-submission system, your application is ready for submission. This may happen when the addition of a substance in food products increases its exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time to levels greatly exceeding the normal consumption and/or poses a potential risk to consumers. In addition to the substances added for nutritional purposes, food supplements may also contain food additives, i.e. substances added to the products for technological reasons (e.g. coating agents for tablets, sweeteners). Based on EFSA’s work, the European Commission reviews and updates the list of vitamin or mineral substances that may be used in food supplements. Article 8 of the Regulation provides a procedure to prohibit, restrict or place under EU scrutiny a substance other than a vitamin Dietary substance needed in very small amounts to support normal growth and maintenance of health in humans and animals. Depending on national legislation in place, some botanicals are considered traditional herbal medicinal plants or food supplements.