The team at Food Compliance Int. has reviewed thousands of food supplements adjusting their composition and labeling for EU compliance. Our thorough analysis include proposals for reformulation and adjustments in case of multiple jurisdictions and languages. In addition to product review we have successfully represented individual firms as well as industry associations before national authorities, the European Commission, opening EU markets to their products, annulling restrictions on the use of botanicals, or unjustified low levels of vitamin and minerals
In the EU, food supplements are regulated under Directive 2002/46/ EC. Directive 2002/46/EC lists the vitamins and minerals, as well as the forms of these nutrients, that may be used in the manufacture of food supplements.
The use of other substances (such as amino acids, essential fatty acids, fiber and various plants and herbal extracts), maximum and minimum levels of vitamins and minerals, purity criteria or tolerance margins remain subject to the national laws of the EU countries and Articles 34-36 of the Treaty (free movement of goods) A recent initiative by Belgium, France and Italy seeks to harmonize the legislation of the EU countries on botanicals permitted in food supplements.
The so-called BELFRIT list is the first step towards harmonization of the use of other substances throughout the EU.
Fortified foods are regulated under Regulation (EC) No 1925/2006. As with food supplements, Regulation 1925/2006 has harmonized the use of vitamins and minerals by establishing positive lists of nutrients and their forms. Vitamins and minerals may not be added to unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish, and beverages containing more than 1,2 % by volume of alcohol, with some exceptions.
As it is the case with food supplements, the addition of other substances with a nutritional or physiological effect remains subject to national laws of the Member States and Articles 34-36 of the Treaty on the Functioning of the European Union (free movement of goods). The Union Registry on the addition of vitamins and minerals and of certain other substances to foods lists the vitamins and minerals which may be added to foods, but is still silent as to the use of other substances.
Around 75% of our clients are manufacturers or distributors of food supplements, and we consider our expertise in this sphere unrivaled in the EU.
We advised the world's number one online food supplement store in their expansion in the EU with their own line of products. We analyzed composition and labelling of their products, classified them and placed them on several EU countries.
We assisted the Spanish food supplement industry in ensuring the Spanish authorities implemented the mutual recognition principle in favour of herbal food supplements marketed in other EU countries.
We advised one of the world's leading food supplement distributors in their strategy to sell their products in the EU. We suggested changes to their formulas and labels for EU compliance and successfully used mutual recognition to place them in several EU markets.
During the last 15 years, Food Compliance Int. has successfully registered thousands of food products for manufacturers worldwide. We provide full support in placing food product on the market in the EU, including a complete assessment of the composition and labeling of the food for compliance in the EU law and the Member States of prior notification, the first placing on the market in the EU and subsequently in the rest of the EU, benefiting from the mutual recognition principle
Directive 2002/46 allows Member States to establish a notification procedure for the placing on the market of food supplements. Most Member States have implemented such procedure, in practice often resembling a pre-market authorization.
Before the first placing on the market of a food supplement, compliance of the composition and labelling in the EU law and the national Member State of first notification should be ensured. Directive 2002/46/EC lists the vitamins and minerals, as well as the forms of these nutrients, that may be used in the manufacture of food supplements.The use of other substances (such as aminoacids, essential fatty acids, fibre and various plants and herbal extracts), maximum and minimum levels of vitamins and minerals, purity criteria or tolerance margins remain subject to the national rules of the Member States.
The Member State where a food supplement is first placed on the market should be chosen strategically. Not only should the product comply with the national rules of this Member State, other factors should be taken into account, such as the length of the notification procedure and the issuing of a registration letter, which facilitates subsequent notification in other Member States on the basis of mutual recognition,
During the last 15 years, Food Compliance Int. has successfully registered thousands of food products for manufacturers worldwide.
Foods to which vitamins and minerals have been added are regulated under Regulation 1925/2006 and are subject to a notification requirement in 18 of the 28 Member States. The notification procedures for fortified foods are similar to those for food supplements.
As with food supplements, Regulation 1925/2006 has harmonized the use of vitamins and minerals by establishing positive lists of nutrients and their forms. The addition of other substances with a nutritional or physiological effect remains subject to regulations of the Member States.
Therefore, before placing a fortified food on the market in the EU, it should be ensured that the composition and labelling of the product complies with EU law and the national laws of the Member State where it is first placed on the market,
Not all foods for particular nutritional uses are subject to a national notification procedure. Directive 2009/39 and its various implementing Acts establish a notification requirement for infant formulae and follow-on formulae and those PARNUTS which are not listed in the Annex of Directive 2009/39, such as foods for people intolerant to gluten. It further allows Member States to have a notification procedure for foods for special medical purposes. Foods for sports people are subject to a notification in some Member States.
“We advised the world’s number one online food supplement store in their expansion in the EU with their own line of products. We analyzed composition and labelling of their products, classified them according to EU regulations and placed them on the market in several EU countries.”
“In the vitamins and minerals sphere, following our action before the European Commission, Spain dropped the maximum limits of vitamins and minerals present in food supplements and has adopted a flexible approach towards the application of the mutual recognition principle”
“We assisted the Spanish food supplement industry in ensuring the Spanish authorities implemented the mutual recognition principle in favour of herbal food supplements marketed in other EU countrie
We have experience in the assessment of food labels, and we regularly advise food business operators on questions of compliance and practical application of Regulation 1169/2011 on the provision of food information to consumers, category specific aspects, and the national rules complementing this framework
The EU constantly strengthens the rules on the provision of food information to consumers, with the aim of preventing misleading practices and that consumers are guaranteed their right to information. This objective needs to be compatible with the free movement of safe and wholesome foods, which is an essential aspect of the internal market.
The EU has recently adopted Regulation (EU) No 1169/2011, ensuring an EU harmonised approach to the provision of food information to consumers. These Regulations affect all aspects of food labelling, such as the legibility of information, rules regarding the presentation of allergens for prepacked foods and non-prepacked food, and detailed provisions regarding the nutrition declaration. These labelling requirements are equally applicable to online sales, distance-selling or shops.
Since Regulation 1169/2011 is applied since December 2014, the Member States are now beginning to interpret these rules. The Commission has offered Guidance to ensure the interpretation of some aspects of the rules is homogenous.
However, Member States may still apply their own regulations to other important aspects of labelling, such as some aspects of labelling for non-prepacked foods, or clean labelling statements such as “natural” or “GMO-free”.
In addition, different products such as food supplements, functional foods, meal replacements, energy drinks or fruit juices need to comply with the specific framework applicable to those types of products.
“We advise our clients to ensure their labels are in compliant in the EU and at national level, as well as help ensure their labels are translated into the languages of the Member States where
they wish to market their products.”
“We advised a drinks association regarding the labelling of their products and the nutritional
information, in a complex case where several different frameworks simultaneously apply.”
“We advised the world’s number one online food supplement store in their expansion in the EU with their own line of products. We analyzed composition and labelling of their products, classified them and placed them on several EU countries.”
We advise our clients on the placing of the market of food products in the entire EU on the basis of the mutual recognition principle. We help to strategically choose the Member State of first placing on the market, thus paving the way for access to the market in the rest of the Member States. During the last 15 years, Food Compliance Int. has successfully placed thousands of food products on the EU market by virtue of the mutual recognition principle
We design the regulatory strategy for firms willing to expand into the EU market and hlep choosing the country of first commercialization for the subsequent application of the mutual recognition principle.
By virtue of the mutual recognition principle, products lawfully marketed and/or manufactured in a Member State can be sold throughout the EU even if they do not comply with the national rules of the Member State of destination.
In the food sector, the favorable application of this principle is often the object of hindering measures from the enforcing authorities. In reality, this principle, cornerstone of the internal market, can only be hindered in a few number of cases, principally related to public health reasons.
The mutual recognition principle applies in the areas that are not harmonized by EU legislation, such as the maximum levels of vitamins and minerals and the addition of other substances with a nutritional or physiological effect to food supplements and fortified foods, which remains subject to national laws of the Member States.
The Member State where a food is first placed on the market should be chosen strategically. Not only should the product comply with the national requirements of this Member State, other factors should be taken into account. For products subject to a notification requirement, obtaining registration proof from the first Member States facilitates subsequent notification in other Member States on the basis of mutual recognition. For this reason, a first notification of food supplements and fortified foods in Member States such as Belgium, where an official registration number is issued, has proven be be an excellent way to enter the rest of the EU market.
“We advised the world’s most important dairy producer on the extent of application of the mutual recognition principle in relation to the use of nutrition and health claims. ”
“We assisted the Spanish food supplement industry in ensuring the Spanish authorities implemented the mutual recognition principle in favour of herbal food supplements marketed in other EU countries”
“We advised the world’s number one online food supplement store in their expansion in the EU with their own line of products. We analyzed composition and labeling of their products, classified them and placed them on several EU countries.”
We have extensive experience ensuring compliance of nutrition and health claims made on foods. We help our clients achieve compliance, make optimal use of the available possibilities under the Regulation and prepare, file and coordinate applications for new health claims. Our work in this area is highly recognized, not only by our clients but also by the EU institutions. Our experience in this field includes working with one of the world’s leading dairy products manufacturer in their high-profile Article 13(5) and 14 applications
The use of nutrition and health claims is harmonized under Regulation 1924/2006. The Regulation establishes when and how information on particular beneficial nutritional properties of a food and on the relationship between a food and health can be communicated to consumers. The rules apply to any voluntary type of message in the labelling, presentation and advertising of foods, whether in written, pictorial, graphic or symbolic.
We assisted a food sector association in advocating a legal policy revision by the European Commission in relation to health claims
Health claims are claims that state, suggest or imply that a relationship exists between a food category, a food or one of its constituents and health. The authorized health claims and their conditions of use can be found in the EU Register on nutrition and health claims.
Examples of health claims are "Vitamin C contributes to the normal function of the immune system" and "Essential fatty acids are needed for normal growth and development of children".
For botanical substances, there is in addition the possibility to use the so-called "on hold" claims, whose evaluation by the EFSA or whose consideration by the Commission has not yet been completed. Those claims can be used, provided that they comply with Regulation 1924/2006 and with existing national provisions.
Certain names can benefit from a (partial) exemption from the rules of Regulation 1924/2006, provided that the conditions are met. Examples are trademarks, brand names and fancy names, as well as generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages. For the latter, there is a specific application procedure to obtain a derogation allowing the use of the denomination without an accompanying related claim.
Nutrition claims are claims that state, suggest or imply that a food has particular beneficial nutritional properties. Examples of nutrition claims are "high fibre", "contains vitamin C" or "light".
Only the authorized nutrition claims listed in the Annex of Regulation 1924/2006 may be used, provided that the conditions of use are met.
The wording of nutrition and health claims does not have to be exactly that of the authorized claim. A certain degree of flexibility is allowed, as long as the used claim has the same meaning for the consumer as the authorized claim. The flexibility principle allows food business operators to personalize their claims and use more marketing-oriented formulations.
Regulation 1924/2006 lays down several general principles for the use of nutrition and health claims. However, the use of nutrition and health claims should also comply with the rules on voluntary food information in Regulation 1169/2011 on food information to consumers. For example, it is not allowed to claim that a food possesses special characteristics, when in fact all similar foods possess such characteristics.
APPLICATIONS FOR NEW HEALTH CLAIMS
Regulation 1924/2006 provides several procedures for the authorization of new health claims. Application dossiers should specify the food or food ingredient for which the application is made and provide solid scientific substantiation of the claimed health benefit.
A particularly interesting possibility is the request for the protection of proprietary data. This allows for restriction of the use of the claim in favour of the applicant during five years, effectively providing the food business operator a monopoly on the use of his claim.
“We represented one of the largest dairy food and water producers in the world in a high profile application for the use of the term “probiotic” in the EU, coordinating the work in several EU countries.”
“We advised one of the world’s leading companies in the healthcare and medical products industry with their communication strategy on health claims on their flagship line of products.”
“We assisted a food sector association in advocating a policy revision by the European Commission in relation to health claims”
All food additives, including colors, sweeteners and other functional classes (e.g. anti-caking or bulking agents), are regulated under Regulation (EC) No 1333/2008. The use of additives presents several challenges, including maximum limits, restrictions as to the food categories where it can be used, authorized functions, whether clean labelling is possible using certain additives, etc. We help our clients navigate the regulatory hurdles arising from this category of food ingredients
Regulation (EC) No 1333/2008 sets the Community lists of food additives authorized in foods, food additives, food enzymes, flavorings, nutrients and other substances added for nutritional and/or physiological purposes. It also establishes the conditions attached to their use (mainly maximum limits) and specific labeling requirements. Food additives authorized under Directives 94/35/EC, 94/36/EC and 95/2/EC may be used pending their review by the European Commission, due by January 20, 2011.
We help our clients navigate the regulatory hurdles arising from the use of this category of food ingredients
Flavorings are regulated by Directive 88/388, Regulation 2232/96/EC and Regulation (EC) No 1334/2008. Regulation 2232/96/EC lays down a Community procedure for the evaluation of flavoring substances. Based on the outcome of this evaluation, the Commission will adopt a positive list of flavoring substances by December 31, 2010. Most of the provisions laid down in Regulation (EC) No 1334/2008 will apply as of January 20, 2011.
COMMON AUTHORIZATION PROCEDURE
Regulation (EC) No 1331/2008 has established a common authorization procedure for food additives, food enzymes and food flavorings.
“We have advised major food ingredient manufacturers on the classification of substances authorized both as additives and nutrients.”
“We advised several energy drink manufacturers on their replacement of their sweeteners by stevia, and guided through the use of appropriate “natural” labelling ”
“We helped on the due diligence of one of the largest food additives manufacturers in their acquisition of a natural food colors firm”
All food policy in the EU is drafted with a double objective: ensuring a high level of protection of human life and consumers' interests and ensuring the effective functioning of the internal market. We help our clients navigate between those overarching principles, and ensure compliance with food safety whilst ensuring that their products can be freely marketed throughout the European Union
Food safety standards in the EU are considered among the stricter in the world. The shift towards a harmonized set of principles on food safety law came after a series of food incidents in late 1990s. The crises manifested the need to establish general principles and requirements concerning food and feed law at EU level. Regulation (EC) No 178/2002 laid down the general principles and requirements of food law (General Food Law Regulation) in all 28 EU countries and set up the EU's independent agency responsible for scientific advice and support, the European Food Safety Authority (EFSA).
We help our clients ensure compliance with the key elements of general food safety, including traceability, responsibilities of food/feed business operators, risk assessment and transparency.
“We helped one of the world’s leading pharmaceutical companies with the negotiation with the authorities in connection with the withdrawal of one of their flagship products from the market”
“We helped several governments to draft their food safety policy and set up their food safety national agencies”
“We helped the largest manufacturer of a best-selling novel food in the safety aspects of their food manufacturing processes”
Novel foods and ingredients are regulated under Regulation 258/97. It stipulates that foods and food ingredients belonging to certain categories which have not been used for human consumption to a significant degree within the EU before May 15, 1997 require an authorization before they can be placed on the market.
The responsibility to prove that a food has been consumed to a significant degree before May 15, 1997 lies with the food business operator. Thus, food business operators may be asked by enforcement authorities to provide such proof.
The EU Novel Food Catalogue gives an overview of the currently obtained information regarding history of use and lists mostly botanicals. The list has however no normative status and can therefore only be relied on as an informative instrument.
For botanical extracts, the novel food status is particularly complex. This is because there is no consensus among the Member States to which extent the novel food status of an extract coincides with that of the plant.
Food Compliance Int. has extensive expertise in the field of novel foods. We advise our clients on the novel food status of ingredients and we prepare application dossiers for full authorizations and substantial equivalence authorizations
Novel foods and novel food ingredients require an authorization. This authorization can be granted solely by virtue of a positive assessment by a Member State, or may involve an assessment by EFSA. Application dossiers should contain extensive safety information about the food or ingredient.
Authorizations are currently only valid for the applicant The draft for a new novel foods Regulation, which is currently in the process of being adopted, foresees a generic system, in which authorized novel foods may be used by any food business operator, provided that the conditions are met, unless the applicant requests protection of proprietary data, which gives him an exclusive right to use the food or ingredient.
Already authorized novel foods and novel food ingredients may be placed on the market by others than the applicant, if it can be established that the food or ingredient is substantially equivalent to the food or ingredient for which an authorization has been issued. The application is done by submitting a dossier proving substantial equivalence to one of the EU Member States. The food may be marketed after a positive assessment by a Member State and a notification before the European Commission.
“We helped in obtaining a full novel food authorization for chia oil (Commission Decision 2014/890/EU, from preparing the scientific dossier to the follow-up during the authorization procedure.”
“We advised a leading producer of botanical extracts on the novel food status of several of their ingredients. We helped them defending the non-novel status applying Regulation 258/97. ”
“We have obtained substantial equivalence authorizations for numerous clients, in particular for chia seeds. ”
The increasing overlap between foodstuffs intended for particular nutritional uses (“PARNUTs”), including sports foods or “foods intended for the expenditure of intense muscular effort, especially for sportsmen” and other categories of food, including food supplements is at the origin of the recent abolition of the whole category of PARNUTs and its replacement by Regulation 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control, which will be applicable from July 20, 2016
We have an extensive knowledge in placing sport foods in the different EU countries
There is no EU-wide definition of sport food, or what compositional or labelling requirements sport foods should comply with (except from the general framework set forth in Directive 2009/39 on PARNUTs).
As a consequence of the lack of EU-wide harmonization, EU Member States do not follow a uniform interpretation of borderline issues around sport foods (for example, when a product is a sport food and when it is a food supplement), and a case by case analysis and strategy for each product is recommended prior to placing sport foods on the EU market.
Examples of sports foods include protein bars supporting muscle building and fast recovery; amino-acids supplements to meet the expenditure of intense muscular effort or carbohydrate gel with extra sodium to compensate sweat loss.
WEIGHT MANAGEMENT FOODS
Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction lays down compositional and labelling requirements for foods presented for use in energy restricted diets that are total daily diet replacement or individual meal replacement for weight control. The claims that may be made on these types of products are very limited.
Regulation 609/2013 will enter into force on July 20, 2016, and will apply only to products on the total diet replacement for weight control (also known as low calorie and very low calorie diets). The Commission must also adopt specific measure detailing compositional and labelling rules for these products.
FOODS FOR SPECIAL MEDICAL PURPOSES
These foods are intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods.
Commission Directive 1999/21/EC on dietary foods for special medical purposes (as amended by Directive 2006/141/EC) sets out rules for the composition and labelling of foods that are specifically formulated, processed and intended for the dietary management of diseases, disorders or medical conditions of individuals who are being treated under medical supervision.
“We advised a US online meal replacement store in their expansion in the EU. We assisted in analyzing the composition and labelling of their products for several EU countries”
“We advised the world’s number one online food supplement store in their expansion in the EU with their own line of products. We analyzed composition and labelling of their products, classified them and placed them on several EU countries.”
“We represented a multinational company in the development of a medical food based on their best selling product
We have experience in a wide variety of areas including EU regulation and policy (compliance, animal testing), labelling and advertising issues, product registration (through the European Cosmetics Products Notification Portal), classification procedures (distinction between cosmetics, medicinal products, biocides or medical devices); and product liability (withdrawals, recalls), among others
We often review the composition and labelling of cosmetic products to be placed on the EU market, notify them before the European Commission and advise on regulatory issues arising from their marketing
Whilst giving cosmetic product companies more freedom to formulate their products when using substances other than colorants, preservatives and UV-filters; Regulation 1223/2009 sets detailed requirements regarding the responsibility of cosmetic product companies along the supply chain, as well as establishes detailed obligations for proving and documenting the safety of cosmetic products. The European Union and Member State authorities also pay close attention to claims made on cosmetic products, as well as to the demarcation of cosmetic products from other categories of products such as medicinal products, biocides and medical devices.
“We represented a U.S. cosmetics firm before the European Commission for the amendment of the relevant EU guidelines on cosmetic products to include language suitable for our client’s products”
“We advised a US company on the impact of animal testing carried out outside the EU due to third country requirements, and compliance with other regulatory aspects such as REACH”
“We advised on the impact of the Product Information File and Safety Assessor indications on cosmetic product labels.”
Food Compliance Int. advises clients on the composition and labeling of feed and pet products and has specific expertise on the regulatory framework for animal by-products
We performed an EU wide regulatory due diligence check for the $2.2 billion acquisition of the world's largest animal by-product rendering company.
The rules on the marketing and labelling of feed are laid down in Regulation 767/2009. Feed materials must be included in the EU Catalogue of feed materials, listed in Commission Regulation 68/2013. In order to be included, feed materials must be notified before the representatives of the European feed business sectors.
Regulation 767/2009 lays down general labeling requirements for feed and specific requirements for feed materials, compound feed, feed intended for particular nutritional purposes, pet food and contaminated feed.
Feed additives are regulated under Regulation 1831/2003. The regulation specifies the categories of additives, their conditions of use and their specific labeling requirements.
Feed additives need to be authorized in accordance with an EU procedure. The application dossier needs to contain studies on the safety and efficacy of the additive.
Animal by-products and derived products are parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption and products derived therefrom.
Strict rules have been laid down in Regulation 1069/2009 on how animal by-products may be disposed and used, depending on the category of by-product. Only category 3 material may be used for the production of feed and pet food.
Certain activities involving the handling of animal by-products are subject to prior approval by the national authorities of the Member States.
The dispatch of animal by-products within the EU is subject to restrictions and may be refused by the Member States.
“We performed an EU wide regulatory due diligence check for the $2.2 billion acquisition of the world’s largest animal by-product rendering company”
“We advised a pharmaceutical commpany on the classification as a feed additive of an innovative borderline product for dogs and advised on the contents of the application dossier for the product”
“We advised a large food and feed supplement manufacturer on the composition, labeling and placing on the market in the EU of a feed supplement”