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Food law

Foodstuffs are, similarly to all other products being placed on the market of the European Union, subject to the principle of free movement within the Common Market. In order to properly protect consumers as well as sound competition, it therefore quickly became necessary, in this sensitive area dealing with human health, to harmonize a number of rules dealing both with sanitation and, increasingly, with nutrition.

Food law applies to the entire food chain, including products which are not foodstuffs themselves (such as pre-harvest agricultural production) but could potentially be included in the food chain.

As such, foodstuffs are highly regulated at the European level, with most general rules provided in the fundamental Regulation 178/2002 “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” dated January 28, 2002, in numerous rules specific to products or product categories (the so-called “vertical” rules) and in rules which apply to all products (the so-called “horizontal” rules).

Regulation 178/2002 has created a very broad definition of foodstuffs, which includes nearly all products which are normally ingested, apart from medicinal products. Finding the limit between what constitutes a medicinal product and a foodstuff can be difficult, especially since medicinal products can be characterized not only by their function but also by how they are presented, if they claim to have prevention or curing properties. Questions regarding this limit are difficult, especially in matters of food supplements, which under European Union law are considered to be a category of foodstuffs and therefore subject to the relevant regulations. The same applies to other products intended for specific use or which carry strong health claims. This is a major issue for companies. Their products could well be prohibited and companies could therefore be held liable for illegal practice of pharmacy. It is recommended to exercise a high degree of caution in these matters.

Regarding foodstuffs, national laws have increasingly had less autonomy as most products are regulated at the European Union level by Regulations of direct application which are progressively replacing former directives which needed transposition into national law (such as the labeling and presentation of foodstuffs, or the use of additives). However, as in almost all domains governed by European Union law, implementation of these rules is done at the national level. In France, the Consumer Code as well as, for a number of domains, the Rural Code, apply to all products not regulated by Regulations, whether through the transposition of Directives, through fully autonomous rules when they still exist (as they do for some product definitions) or through control procedures and sanctions.

In France, the competent authority on food law issues is the Directorate-General for Competition, Consumption and Fraud Control (DGCCRF – Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes), supervised by the Ministry of Economy. For products linked to animal food and health, the competent authority is the Directorate-General for Food (DGAL – Direction Générale de l’Alimentation), supervised by the Ministry of Agriculture. Inspections are carried out by agents of the decentralized prefectural services, who are part of the Departmental Directorates for Population Protection (DDPP – Directions Départementales de la Protection des Populations).

Regulation 178/2002 provides for a general safety requirement of foodstuffs placed on the market as well as for the principle of liability applied to all operators along the food chain, from agricultural production to delivery to the consumer. For these purposes, each operator has a general obligation to know and keep trace of the origin and destination of all products he has purchased and placed on the market. Operators are also under the obligation to fully cooperate with the authorities, as they can be held liable when a non-conforming product (unfit for human consumption or creating a health risk) has been placed on the market. In these cases, companies (or sometimes the authorities themselves) must adopt measures to withdraw or recall the said products.

When such measures are adopted for products which can move freely within other Member States of the European Union, national authorities will issue a warning through the rapid alert system for food and feed products (RASFF) in order to warn the authorities of the other Member States of the risks associated with the products circulating on their territory and to enable them to take adequate measures. It should be noted that the RASFF can be consulted by anyone via a dedicated website run by the European Commission. The system does not always, however, allow the general public to know precisely which products are affected as it does not publish the name of the companies involved.

The general safety requirement for all foodstuffs placed on the European Union market is also the basis for numerous regulations dealing with hygiene within companies, or composition of foodstuffs as well as labeling and presentation of products.

Prior to being placed on the market, novel foods and novel ingredients (i.e.which were not on the European Union market prior to May 15, 1997) require prior authorization by the Commission after it has received the opinion of the European Food Safety Authority (EFSA). This procedure is long and difficult and, when possible, companies generally prefer to avoid it. Assessing whether a product should or should not be considered novel can in itself be very complex. Our experience shows that this assessment requires close cooperation with scientists, whether internal or external to the company.

Additives are technological ingredients used in foodstuffs (such as coloring agents, sweeteners, thickeners, preservatives) and are also subject to prior authorization at the European Union level. Regulation 1338/2008 deals with the list of authorized additives at the European Union level. This list is frequently amended and supplemented. Additives are classified by foodstuffs for which they can be used along with conditions for their use. An equivalent scheme is being set up for enzymes. Flavorings are also closely regulated.

Processing aids are technological substances used in foodstuffs production processes but which do not have a function within the product. Contrary to additives, they are not regulated at the European Union level. Final products manufactured with processing aids must simply provide guarantees of safety (including for all processing aids residues they may contain). In France however, the use of processing aids is strictly controlled. The current regulation results from a compromise with the European Commission, following a Court of Justice judgment of 28 January 2010. Today, not all categories of processing aids require prior authorization as was the case before. For those which still require such an authorization, the principle of free movement of goods applies.

Furthermore, the limit between additives and processing aids cannot always be clearly drawn for a given process. On this issue as well, cooperation between scientists and jurists is required.

Genetically modified organisms (GMO) and products derived from them require prior authorization before being placed on the European Union market. They are also subject to specific traceability obligations as well as mandatory labeling. This subject is highly political, but it is also very technical and governed by specific legal rules which our firm has been using for a number of years in order to assist its clients in the industry.

In addition to these general rules which deal with the composition of foodstuffs, a number of products are subject to specific rules at the European Union level or, sometimes, at the national level. For example (but this is not an exhaustive list), a number of “vertical” directives can be mentioned (fruit juices, cocoa and chocolate products, mineral waters, jam…) as well as legislation regarding agriculture which puts limitations on the use of certain denominations for dairy products (butter, crème), wines and spirits. It is necessary to exercise caution in checking whether a product is subject to specific regulations at the European Union level or at the national level (as can be the case in France for cheese, fermented milk, yogurts or a number of meat products). This particularly applies when launching a new product. For all these products (and especially for imported products), national rules sometimes also refer to professional codes of uses or to standards, the legal and binding force of which must always be subject to a precise legal analysis, taking into consideration the principle of free movement of goods.

Food law does not only deal with the composition and manufacturing of foodstuffs, it also deals with their labeling and, more generally, the way they are presented. In this respect, the rules are greatly harmonized at the European Union level and increasingly provide for strict requirements for consumer information, which go beyond mere protection from forgery.

The debate on the indication of ingredients’ origin, which results from the horse meat scandal, is a mere illustration of what some have been claiming for a long time. This principle is embodied in the Regulation on food information to the consumer, which came into force in December 2014 (Regulation 1169/2011, the so-called "FIC" regulation) replacing the Directive on labeling. According to this regulation, the origin of a product will have to be determined using customs rules, which are in themselves very complex and require an equally strong knowledge of the subject.

Beyond such technical and relatively new questions such as origin, the essential obligation for a food product’s label is to indicate the denomination of the product (which is not always easy to determine), the list of its ingredients (including additives, but not the processing aids – hence the importance of drawing a clear distinction between the two), allergens (including those originating from processing aids), expiry date and quantity. All this information must be provided in a language that can be easily understood by the consumer. The nutrition declaration is still optional at this date (except for a number of foodstuffs for which the declaration is already mandatory, notably health claims), but will become mandatory for all foodstuffs in 2016.

Optional indications such as claims, which are very important for industrials, are strictly regulated, especially those involving nutrition and health. Pursuant to Regulation 1924/2006, any nutrition or health claim which does not appear on the European Union list of authorized claims is prohibited. Companies may file applications for the validation of new claims by providing a scientific dossier which is subjected to the scrutiny of the EFSA before the Commission reaches its decision on the application. Under certain conditions, scientific studies used for these applications (the so-called “proprietary” data) may allow the applicant to make exclusive use of the claim for five years. The Commission has however considerably reduced this possibility by refusing to award the said protection to studies that have previously been published. The implementation of the nutrition and health claim regulation may also raise questions of interpretation, particularly as to the very notion of "health claim" and as to the precise wordings which can be used for authorized claims.

Contrary to health and nutrition claims, other claims are not harmonized at the European Union level. Such is the case for the very much sought after “natural” claim which is often regulated, but not always, in a restrictive manner, at the Member State level. In France, the DGCCRF has adopted a strict but open attitude, that allows it to admit, under certain circumstances, a “natural origin” claim for products which are not strictly speaking “natural”.

As was said before, the placing of foodstuffs on the market requires a systematic and careful verification of national and European Union rules regarding the status of product and its components, its denomination as well as other obligations in terms of labeling, publicity and the way the product is presented. It may also require taking into consideration other legal principles such as free movement of goods within the European Union, competition law, consumer protection rules and even customs law.

COUTRELIS & ASSOCIES has a long-standing practice in all these domains. A team is dedicated to these questions and handles our clients’ issues on a case by case basis. French, European and International companies have relied on us as to the verification of their product’s compliance to all applicable regulations. A number of trade associations regularly consult us on precise legal issues. We have also assisted companies as part of a larger team consisting of scientists and marketing experts for the launch of new products or advertisements as well as for securing positive anwers for authorization requests. We very frequently work transnationally and for that purpose we team up with specialists in Europe and the United States. Even though we are in regular contact with these experts, we do not have any exclusive relationship with them. We maintain a number of contacts with independent scientists in various specialties (toxicologists, nutritionists etc.) and call upon them according to our clients' needs.

Members of COUTRELIS & ASSOCIES regularly publish articles in a number of specialized publications (FDLI Update, European Food and Feed Law Review-EFFLR), or speak at conferences (FDLI in Washington DC, EFFLR), or offer training courses on specific technical subjects (additives, claims, etc.). They have, since it has started in 1999, taught each semester the “European Union law” part of the online International Food Law and Regulations course of Michigan State University. The firm is also an active member in a number of associations such as the Food and Drug Law Institute in Washington DC (FDLI), the Institute of Food Technologists (IFT) and the European Food Law Association (EFLA) based in Brussels.

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