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    10/12/2012 - Products liability in France : a presentation by Pierre-Yves Rossignol

    PRODUCTS RECALL – PRODUCTS LIABILITY

    IN FRANCE – A PRESENTATION

    Pierre Yves Rossignol Partner

    91, rue du Faubourg Saint Honoré - 75008 Paris T : +33.1.53.43.12.67 - F : +33.1.53.43.15.00 www.granrut.com

    Product Recall

    Very early, the courts considered that the Case Law rules on legal liability (contractual, contract, criminal or quasi-criminal liability) should apply to manufacturers and distributors of products and to service providers, to enable the compensation of victims, regardless of criminal actions provided for in the event of murder or unintentional injuries.

    The increasing number of threats to consumer safety, resulting in particular from the growth in risks of error caused by mass production, made preventative action by the public authorities necessary.

    The legislator therefore made the first company to market a product, whether the national producer or importer, responsible for the obligation to control the compliance of the product with the prescriptions applicable to it.

    In addition to this general compliance obligation, there is a principle of general product safety, also applicable to services, leading to obligations for professionals of information, monitoring of products, indicating risks and even withdrawal of products.

    The public authorities received wide intervention powers to prohibit any product or service presenting a danger to the health and safety of consumers or order that they are recalled.

    With respect to terminology and in the strict sense of the word, we speak about “withdrawal” of products when they have not yet been launched for circulation to the public or when there is a threat or realisation of personal injury ;

    The term “recall” of products must be used when they are in the hands of the end consumer, the public, and when it is necessary to repair the defects in the product, regardless of the damage it has or could cause to users or third parties.

    1. Product safety In addition to the two general systems of contract and tort liability, which are mutually exclusive, a French statute dated 19 May 1998 transposed into French law the 1985 EC Directive 85/374 on liability for defective products. It introduced a specific system of strict product liability. Pursuant to Article 13 of this Directive, this strict liability system should not affect any rights an injured person might have under "the rules of the laws, of contractual or non-contractual liability" or "a special liability system". Accordingly, Article 1386-18 of the French Civil Code provides that the strict product liability system shall exist alongside the contractual or tort liability systems. Strict product liability (Articles 1386-1 to 1386-18 of the French Civil Code, Article L221-1 of French Consumer Code) : the statute dated 19 May 1998 (Act No. 98-389 on liability for defective products), implementing the Directive, introduced a new title, "liability for defective products", into the French Civil Code. This set of articles has been amended by two successive statutes, a "Simplification of the Law" statute dated 9 December 2004, and a statute of 5 April 2006. This specific system of product liability is based on strict liability. It enables an injured party to bring an action without having to prove any breach of contract, fault or negligence on the part of the producer, the cornerstone of this system being the notion of "defect". The defective product is defined by Article 1386-4 of the French Civil Code as "a product which does not provide the safety which a person is entitled to expect", taking all circumstances into account. The producer owes the same duty towards any injured party, whether a contracting party or a third party. For strict product liability to apply, the claimant must prove that the product was defective, the existence of a damage (bodily injury or damage caused to property), and the causal link between the defect and such damage. Under the terms of article L221-1 of French Consumer Code “products and services must, in normal conditions of use or in conditions that a professional could reasonably predict, present the safety that can legitimately be expected and not damage the health of persons”.

    On the basis of this principle, professionals are bound by information, product monitoring and product risk indicating obligations. These obligations were established by the French orders 2004-670 of 9 July 2004 and 2008-810 of 22 August 2008, transposing the directive 2001/95 of 3 December 2001.

    a. Product risks

    The regulations concerning the general safety of products and services applies in the alternative : it concerns the products and service provisions which are not subject to specific legislative provisions or community regulations with the purpose of protecting the health or safety of consumers (French Consumer Code art. L. 221-8).

    In particular, the regulations do not apply to foodstuffs ; the latter are subject to the prescriptions set forth by the regulation CE 178/2002 of 28 January 2002, as amended, which sets the procedures concerning the safety of such products.

    Furthermore, the regulations do not apply to antiquities and second-hand products which, before use, require repair or renovation when the supplier has informed the purchaser thereof (French Consumer Code art. L 221-1-1).

    b. Safety standards and conformity with standards Under Article L. 212-1, paragraph 2, of the Consumer Code, it is the responsibility of who places the product on the market "to verify that it complies with applicable regulations" i. French legislation

    A product which is assumed to fulfill the general safety obligation set forth in article L 221-1, with respect to the risks and risk categories covered by the standards applicable to it, when it complies with the national standards transposing European Union standards, the references of which were published by the European Commission in OJUE.

    In other cases, the compliance of a product with the general safety obligation is assessed taking into consideration in particular the following information when it exists (French Consumer Code new art. L 222-3, resulting from the order of 22-8-2008) :

    - the national standards transposing European standards applicable to the product other than those of which the reference is published in the OJUE pursuant to article 4 of the directive 2001/95 ;

    - the decision of the Consumer’s Committee and other French standards ;

    - best practice guides concerning product safety in force in the sector in question ;

    - the current state of knowledge and technology ;

    - the safety levels consumers can legitimately expect.

    ii. EU standard published In OJ Article L 221-1 of the French Consumer Code provides that a product is considered as fulfilling the general safety obligation when it is in accordance with the specific regulations applicable to it with the purpose of protecting the health or safety of consumers, resulting from the order of 22-8-2008.

    A product which is assumed to fulfill the general safety obligation set forth in article L 221-1, with respect to the risks and risk categories covered by the standards applicable to it, when it complies with the national standards transposing European Union standards, the references of which were published by the European Commission in OJUE pursuant to article 4 of the directive 2001/95 of 3 December 2001 concerning general product safety (French Consumer Code new art. L 222-2, resulting from the order of 22-8-2008).

    Pursuant to the directive, the French state must publish the references of these national standards.

    c. Compliance by sectors The law 98-535 of 1 July 1998 concerning the reinforcement of health vigilance and health safety supervision of products intended for persons, repeated in the French Public Health Code and amended several times, established public organizations responsible for compensating for insufficiencies, on the one hand, in the regulations and inspections aimed at guaranteeing the health safety of food and health products and, on the other hand, health vigilance methods (collection of information concerning the health of the population and alert procedures in the event of a threat to public health).

    The Consumer Safety Committee has a general role to advise and propose measures to improve the safety of products or services.

    Four public organizations are responsible for the food and health sectors : the Institut de veille sanitaire, Agence française de sécurité sanitaire des produits de santé (Afssaps), Agence française de sécurité sanitaire des aliments (Afssa) and Comité national de la sécurité sanitaire.

    i. Prior approval — medicines, foods

    medicines : Agence française de sécurité sanitaire des produits de santé (French agency of health product safety) : Afssaps participates in the application of laws and regulations concerning all the stages of manufacture and distribution of products for health purposes intended for people and products for cosmetic purposes (French Public Health Code art. L 5311-1, para. 2).

    For example, this covers medications, medical devices (instruments, machinery or products intended to be used on persons for medical purposes), labile blood products, organs and tissue of human or animal origin, gene and cell therapy products, contraceptive products and products intended for the maintenance of contact lenses.

    Afssaps must assess the benefits and risks linked to the use of these products at any suitable time, in particular when a new aspect is likely to challenge the initial assessment (French Public Health Code art. L 5311-1, para. 21).

    It is also responsible for monitoring advertising for all products, items, devices and methods which have a health purpose (French Public Health Code art. L 5311-1, para. 23). Furthermore, it takes, or asks the competent authorities to take, the health policy measures necessary when the health of the population is threatened (French Public Health Code art. L 5311-1, para. 6).

    Comité national de la sécurité sanitaire (national health safety committee) : The Comité national de la sécurité sanitaire, chaired by the minister of health, is responsible for analyzing events likely to affect the health of the population, comparing the information available and managing coordination of the intervention of state services and public institutions placed under its supervision, in particular for the management, monitoring and communication of health crises ; it must also coordinate the scientific policy of the Institut de veille sanitaire and the two French health safety agencies (French Public Health Code art. L. 1413-1).

    Institut de veille sanitaire (Health Vigilance Institute : Institut de veille sanitaire, a public establishment placed under the supervision of the minister of health, is in particular responsible for the following (Public Health Code art. L 1413-2) :

    - carrying out ongoing surveillance of the state of health of the population, by taking part in collecting and processing data on the state of the health of the population for epidemiological purposes ;

    - guarantee health supervision and vigilance, in particular by prospectively detecting the risk factors likely to affect the population’s health ;

    - immediately alert the minister of health in the event of a threat to the population’s health, whatever the origin thereof, and recommend any appropriate measure or action to prevent this threat being realized or reduce the impact thereof ;

    Food : Agence française de sécurité sanitaire des aliments (French food safety agency)

    Afssaps has the task of contributing to guaranteeing health safety in the food sphere, from the production of raw materials to distribution to the end consumer.

    It assesses the health and nutritional risks that may be presented by foods intended for persons or animals, including those which may result from production, transformation, conservation, transportation, storage and distribution of foodstuffs, and in particular animal diseases or infections, the use of foodstuffs intended for animal feed or fertilizing materials and growing media (French Public Health Code Article L 1323-1, par. 2). and distributors, whatever is the type of products produced or distributed.

    d. Types of corrective action (warning, withdrawing from the market, recalling from consumers) The producer has a duty to take all necessary measures to be kept informed of any risk that his or her product may create and, where necessary, to withdraw and recall any product that may endanger the consumers. e. Criminal liability

    When a product or service causes personal injury, the producer, the distributor or the service provider can, as individuals, be held liable :

    - either, in the event of death of the victim, for manslaughter (French Penal Code, art. 221-6, para. 1) ;

    - or, in other cases, for involuntary bodily harm (French Penal Code art. 222-19 and 222-20).

    Article 222-19 of the Penal Code is only applicable if the injuries caused to the victim leads to total incapacity to work for a period of over three months. Otherwise, there is no offence, but simply a minor offence as penalized by articles R 622-1 and R 625-2 of the same Code.

    The fact of causing a third party’s total incapacity to work for a period of three months or less nevertheless constitutes an offence when the involuntary bodily harm is a result of evident deliberate breach of a specific safety or prudence obligations imposed by the law or the regulations (Penal Code art. 222-20).

    Legal entities can be declared criminally liable for these offences when they have been committed “on their behalf, by their bodies or representatives”, (French Penal Code art. 121-2, para. 1) (cf. for manslaughter, French Penal Code art. 221-7 and for involuntary bodily harm, French Penal Code art. 222-21 : n° 74720).

    1° Through a law of 10 July 2000, the legislator redefined the criminal liability of individuals in the event of unintentional offences.

    2° Offences of manslaughter and involuntary bodily harm constitute offences. The question has arisen of whether the criminal liability of the decision-makers could be incurred for a crime of poisoning in cases where they exposed a larger or smaller number of persons to the risk of contracting fatal diseases (for example, AIDS through contaminated blood transfusion, lung cancer through the use of asbestos for insulation, other cancers through atomic radiation or even Creutzfeldt-Jacob disease through the use of meat or meat-based products contaminated by the agent responsible for “mad cow” disease).

    The Court of Cassation responded negatively. Indeed, if the crime of poisoning is the fact of making an attempt on the life of others by using or administering substances likely to lead to death (French Penal Code art. 221-5), simply being aware of the fatal nature of the substance administered is not sufficient to characterize homicidal intention (Cass. crim. 2-7-1998 : RJDA 10/98 n° 1163).

    Therefore, accusations of manslaughter and involuntary bodily harm, possibly aggravated by evidently deliberate breach of a safety or prudence obligation imposed by the law or regulations (French Penal Code art. 221-6, 222-19, 222-20 and R 625-2), are the only ones which, unless there is proof of the intention of bodily harm, can be upheld against economic operators accused, due to their own fault, of having exposed others to a risk of contamination, disease or death.

    3° The version of the Penal Code which came into force on 1 March 1994 created the fault of deliberating endangering others (French Penal Code art. 121-3, para. 2).

    This not only constitutes an aggravation of the offences of manslaughter or involuntary bodily harm (French Penal Code art. 221-6, para. 2, art. 222-19, para. 2, art. 222-20 et R 625-3) but also an independent offence.

    Indeed, article 223-1 of the Penal Code penalizes, with one year of imprisonment and a fine of €15,000 the fact of directly exposing others to an immediate risk of death or injury likely to lead to mutilation or permanent disability through the evidently deliberate breach of a specific safety or prudence obligation imposed by the law or regulations.

    Contrary to the offences of manslaughter or involuntary bodily harm, imprudence can therefore be penalized even if no damage occurs. This is therefore an offence of prevention, which penalized not the realized risk but simply exposure to this risk.

    2. Obligations of producers and distributors a. Sources of duties i. Statute It is the law of 1 August 1905, now codified in articles L. 212-1 and following of the Consumer Code, which served to support the determination of standards. Certain provisions of the Act gave powers to the government to define "composition, name of goods of any kind, treatments which they may be lawful object, the characteristics that make them unfit for consumption". Thousands of regulations derived from this Law, and set the conditions for marketing of any product.

    Principle of prohibition or regulation : Chapter I, article 1 of the law of 10 January 1978, sets forth the principle :

    “Products, items or devices of which one or more characteristics, in normal conditions of us, present a danger to consumer health or safety, are prohibited or regulated in the conditions defined hereinafter” (Law no. 78-23, 10 Jan. 19878, art. 1, JO 11 Jan.).

    In view of the particularly strict nature of these provisions, the law emphasizes the fact that they must be proportionate to the danger presented, as their purpose is to prevent or stop the danger. The fact remains that safety must now be treated as such and no longer as accessory to the compliance of the product.

    Principle of withdrawal : Article 2 of the law of 10 January 1978, by giving the minister or ministers in question the power to suspend, for a maximum of one year, the manufacture, import, etc., of the product concerned, also confers upon them the possibility, when there is serious or immediate danger to consumer health or safety “to organize the withdrawal in all locations where it is located” and “order the destruction thereof when this constitutes the only means to stop the danger” (L. no 78-23, 10 Jan. 1978, art. 2, JO 11 Jan.).

    It is also moreover specified that these provisions are also applicable to services provided (see L. no. 78-23, 10 Jan. 1978, art. 3, JO 11 Jan.).

    Producers and distributors shall take all useful measures to contribute to fulfillment of all safety obligations set forth by articles L 221-1 s. of the French Consumer Code (French Consumer Code art. L 221-1, para. 8, resulting from the order of 22-8-2008).

    Article L. 221-1-2, II of the French Consumer Code concerning general product safety – Ord. No. 2008-810, 22 August 2008, JO 23 August) stipulates :

    The producer shall adopt the measures which, in consideration of the characteristics of the product it supplies, enable it :

    1) to keep informed of the risks that the products it distributes may present ;

    2) to undertake the actions necessary to control these risks, including withdrawal from the market, adequate and effective warnings to consumers and recalling from the consumers products already on the market.

    These measures may in particular consist of carrying out tests using surveys or by indicating on the product or its packaging the instructions for use, identity and address of the producer and the reference for the product or batch of products to which it belongs. This information may be made compulsory by a ruling by the minister responsible for consumers or the minister or ministers concerned.

    Under Article L. 212-1, paragraph 2, of the Consumer Code, it is the responsibility of who places the product on the market "to verify that it complies with applicable regulations". The difficulty is to determine who is responsible for first placing the product on the market and assess compliance with.

    For the French case law, it is the importer of a foreign product to ensure that the product complies with French standards, that it has already passed through or not a country of the Union.

    ii. Contract 1. Pre-market obligations

    Information requirement : public authorities can take, by administrative regulation, the necessary measures as regards :

    - modes of presentation or markings of any kind on the goods themselves, packaging, invoices, business documents or marketing materials, in particular regarding : the nature, substantial qualities, composition, content in useful principles, the type, origin, identity, quantity, suitability for use, instruction manuals and the special marks that may or must appear on French goods exported to abroad ;

    - definition, composition and description of goods of any kind, treatments they may be subject to, characteristics that make them unfit for consumption ;

    - definition and conditions of use of terms and expressions advertising in order to avoid confusion.

    Under this text (Article L. 214-1 of the Consumer Code), numerous provisions, applying to particular products, require the manufacturer to inform consumers on the date of use, either on the dangerous nature of the product, either on the intended use.

    Dangerous goods : dangerous goods are subject to accurate requirements for marking and labeling. Any packaging of such substances must mention clearly and indelibly the following information : name or trade name of the preparation, name and full address including phone number of person responsible for placing on the market established within the Community whether the manufacturer, importer or distributor, the name of the chemical substance present in the preparation under certain conditions defined in the text, symbols and indications of danger for the preparation, safety advice such as defined in Annex III and IV of the decree of 16 January 1992 on the label.

    Duty of disclosure : a duty of disclosure lies on the supplier of any hazardous product. Obligation to respect the rules on advertising – Of course the producer of hazardous product also has to comply with legal provisions on advertising of dangerous products.

    Producers are often invited to follow standards : Decree No. 84-74 of January 26, 1984 (Official Journal of 1 February 1984) defines standardization : "standardization is intended to provide reference documents containing solutions to business and technical issues, on products, goods and services, which arise repeatedly in the relations between economic, scientific, technical and social. "Standardization is entrusted to the French Association for Standardization (Tour Europe 92080 Paris La Défense), a private association whose articles are approved by decree.

    Standardization is not only French, it is also international, led by the International Standard Organization (ISO) and the Community Plan under the European Committee for Standardization (CEN).

    In principle, standardization is not binding, except in contracts with the State or local authori-ties. It is a kind of reference to which professionals are willing to bend, in order to use it in their selling compliance with the AFNOR standard. The reference to ISO standards is frequently used in France, to the same purpose, i.e. to indicate the quality of the product or the company that manufactures it.

    2. Traceability, record-keeping The ability to trace origins or traceability is a procedure aimed at automatically following a product from its creation until final valuation. It involves the ability to identify suppliers upstream and clients downstream. It is a quality management tool enabling both fast identification of a product or batch of products in order to be able to withdraw them very quickly and as safely as possible in the event of non-compliance or danger, but also intervention upstream of distribution to inspect, for example, the origin of raw materials or components, and prevent damage from occurring.

    3. Information to consumers – Monitoring – Prohibition to sell

    The producer must supply to the consumer useful information enabling him or her to assess the risks inherent to a product during its normal or reasonably predicted lifespan and to protect himself or herself, when these risks cannot be immediately perceived by the consumer without an adequate warning (French Consumer Code art. L. 221-1-2, I, par. 1 as amended).

    The producer must adopt measures which enable it both to keep informed of the risks the product it distributes may present and also to undertake the actions necessary to controlling these risk, in particular by withdrawing the product from the market, adequate and effective warnings to consumers or recalling this product from them.

    Distributors are not permitted to sell products where they know, on the basis of information in their possession and their position as professional, that they do not comply with the safety obligations defined by articles L 221-1 s. of the French Consumer Code.

    4. Pharmaceuticals

    Any medicine, drug or any other industrially manufactured and any generator or precursor kit must obtain, before its marketing or its free distribution, wholesale or retail, an authorization to be placed on the market issued by the French Agency for Safety of Health Products (Health C. publ., art. L. 5121-8). This authorization is issued for a period of five years and is renewable thereafter for a five years period. The authorization is denied, especially when it appears that the drug or product is harmful under normal conditions of use.

    5. Food

    All food products are not subject to authorization to be placed on the market. But for some products, such permission is required.

    This is so for Food Additives (D. No. 89-674, September 18, 1989, amended several times) for which the principle of the « closed list » is allowed, that is to say that any additive which is not expressly permitted is prohibited. The use of an unauthorized additive causes a possible conviction for tampering with the product.

    When experts have concluded that a formal red dye contained in a drink is not among the products authorized in France or in any other country known to them, adding a dye to a product intended for human consumption is prohibited and that fact alone constitutes the crime of forgery and sale of adulterated liquor.

    As well for chewing gum (D. No. 81-1112, December 15, 1981 : Official Journal of 17 December 1981), for animals for slaughter which must receive the approval of veterinary services (C. rur. , Art. R. 231-17). The same principle applies to the marketing of seeds and seedlings which are established by decree (C. rur., art. R. 661-24. - D. No. 81-605, May 18, 1981). 6. Chemicals

    The marketing of chemicals is subject to a prior declaration to the Administration. The Act of July 12, 1977 on the control of chemicals indicates what is the goal pursued by the legislator. This law seeks to protect humans and the environment against the potential risks posed by chemicals.

    Chemicals are defined in Article 1 as elements and their combinations that are obtained naturally or are produced by industry, whether pure or incorporated in preparations.

    The Act of July 12, 1977 as amended does not apply to chemicals for use in research or drugs, cosmetics and personal hygiene products, materials in contact with food products used in agricultural activities, explosives or additives in food, or to all radioactive substances.

    A declaration to the French Administration must be done before the manufacture for commercial purposes of these chemicals or the import of a chemical that has not already been placed on the French market (L. 12 July. 1977, article 3). If the substance presents dangers for the population and his environment, the manufacturer or importer, must indicate the ways to eradicate the danger.

    The request must be submitted to the Ministry of Environment (D. No. 79-35, 15 Jan 1979), within one month from the declaration to the administrative authority, any manufacturing or any import of the substance, having been the subject of the statement is prohibited. During this period, the administrative authority may register the substance on a list of dangerous products and impose a number of measures that can be extended to the prohibition of production or marketing (L. 12 July. 1977, s. 5.).

    The penalties for violation of the law of 12 July 1977 are determined in article 10 : it is an imprisonment which may last two years and a fine. Seizure of dangerous chemical products can be ordered by the Prefet.

    7. Cosmetic products

    Cosmetics - Following a famous case called "the talc Morhange case" an Act of July 10, 1975 was inserted in the Code of Public Health (Health C. publ., art. L. 658-1 ff) to impose prior tests and reviews for cosmetics and personal hygiene products (that is to say all substances or preparations other than medicines, to be put in contact with parts of the human body or with the teeth or mucosa), in order to clean, protect, maintain them in good condition, change their appearance, their flavor or to correct their odor (C. Health publ., art. L. 5131-2).

    Before placing any cosmetic or personal care product on the market, the producer shall, produce a folder containing all relevant information about the nature of the product, formula, conditions of manufacture or control of its use and instructions, and reviews, notably toxicity and tolerance tests about transcutaneous toxicity for skin or mucosa (C. Health publ., art. L. 5131 - 2).

    The Minister of Public Health may prohibit or simply stopped the marketing of cosmetics or personal care products which present risks for the user. A decree of 22 March 1977 determining the list of poisons that can be used in the composition of cosmetic products or products of body hygiene.

    c. Post-market obligations i. General Official notification : producers and distributors are obliged to immediately notify the authorities (DGCCRF, DGAL or DSCR) if they discover that their product is dangerous (Article L.221-1-3 of the French Consumer Code). The method by which the professional must inform the authorities, including the required information and the appropriate authorities for different categories of products, is prescribed by a Notice to the operators dated 10 July 2004 and a Ministerial order dated 9 September 2004. The failure to notify the French authorities will not give rise per se to a sanction, but it will be taken into account in any civil or criminal proceedings concerning the product. ii Risks reporting

    If the producer or the distributor of a product finds that it does not comply with the general safety obligation set forth in article L 221-1 of the French Consumer’s Code, it must immediately inform the competent authorities thereof, stating the actions it is taking in order to prevent risks to consumers.

    The administrative authorities responsible for receiving such reports are (Ruling of 9-9-2004 art. 3 and notices to economic operators on the establishment of the risk reporting and measures taken obligation for professionals : JO of 10-7-2004 p. 12574) :

    - the directorate general of competition, consumerism and prevention of fraud (DGCCRF), which is competent to receive notifications concerning non-food products (except for products for which notification must be sent to the safety and road traffic directorate) and foodstuffs and animal feed which are not under the remit of the directorate general of food.

    - the directorate general of food (DGAL), which is competent for notifications concerning animal or animal origin foodstuffs intended as human food (except when the danger is connected to an additive, flavoring, technological assistance or material intended to come into contact with these foodstuffs), and for notifications concerning medicinal foods intended for animals when the danger is linked to the medicinal aspect ; iii. Automotive

    iv. Food The general regulations concerning product safety does not apply to foodstuffs, which are covered by the European regulation 178/2002 of 28 January 2002 as amended, establishing the general principles and prescriptions for food legislation, instituting the European Food Safety Authority and setting the procedures concerning the safety of foodstuffs.

    3. Enforcement

    a. Sector organizations i. General consumer products Administration’s powers concerning recall : At the end of a proceeding before the Consumer Safety, the Government may prohibit or regulate the manufacture, import, export, distribution, holding or circulation of the products or services concerned, impose health and safety regulations on the persons involved in creating or distributing them, regulate their labeling, packaging or means of use, set forth obligations concerning information to consumers(Article 2 of the law of 21 July 1983 (which became French Consumer Code, art. L. 221-3) ;

    It can also order that the products are “recalled” to be modified, or for full or part refund or exchange or order that products are “withdrawn” from the market ; It can order their “destruction” when this constitutes the only means of stopping the danger (L. no. 83-660, 21 July 1983, JO 22 July, which has become the French Consumer Code, art. L. 221-3, 3o).

    The minister of consumerism, or the ministers concerned, can issue two types of injunction against certain persons :

    - to request that they make their products or services compliant with safety rules, when regulations exist for them ;

    - to request that they submit their products or services to inspection by an authorized organization, if there are no regulations, in order to verify the existence of dange(French Consumer Code, art. L. 221-7):r.

    Emergency procedure : an emergency procedure is used if there is a serious or immediate danger. In view of the emergency situation, measures taken in these conditions are provisional. These decisions can be taken at two levels.

    Prefectural decision : Alerted by the Administration’s agents, the Prefect (representative of the state in regions) can, within the scope of the department, take “the urgent measures required” (cf. L. no. 83-660, 21 July 1983, art. 6, JO 22 July, which has become French Consumer’s Code, art. L. 221-6). He refers the case as soon as possible to the minister in question and to the minister responsible for consumerism, who must rule, in a joint decision, within fifteen days. Whilst awaiting the ministerial decision, he can have the products seized.

    Ministerial decision : The minister responsible for consumerism and the minister or ministers concerned can take measures at the national level through a decision intended to :

    - for a period not exceeding one year, suspend manufacture, import, export and launch onto the market of the product, whether for consideration or not ; have it withdrawn from all of its locations or destroyed when this is the only means to stop the danger ;

    - order the distribution of warnings or precautions for use, and return for exchange, modification or full or partial refund (cf. L. no. 83-660, 21 July 1983, art. 3, JO 22 July, which has become the French Consumer Code, art. L. 221-5).

    The professionals concerned must be heard no more than fifteen days after the decision date. The products and services recognized as compliant with the regulations in force can be returned to the market.

    Examples of decisions taken within the scope of the law : the Administration has not hesitated to use the procedures made available to it to rule in certain situations brought to its knowledge :

    - decision of 1 June 1989 concerning suspension of the manufacture, import and launch on market and ordering the withdrawal of lighters with the appearance of a toy reproducing a vehicle (Dec. 1 June 1989, NOR : ECOZ8909058A, JO 6 June) ;
    - decision of 2 August 1989 concerning suspension of the manufacture, import and launch on market and ordering the withdrawal of diving masks including an integrated snorkel fitted with a table tennis ball (Dec. 2 August 1989, NOR : ECOC8900081A, JO 4 August).

    ii. alcohols The services of the Directorate of Competition, Consumption and Fraud Control are responsible for making inspections of foodstuffs sold in stores. They can make on the basis of Article L. 218-1 and following of the Code of consumption, take samples, and monitor marketing conditions (including respect for the cold chain). The distribution of alcoholic beverages is also regulated (C. Health publ., art. L. c. 3813-1). It is prohibited for vendors to sell at retail either for consumption on or off premises, drinks from the fourth and fifth groups. The number of drinking establishments is limited. There restricting sales to minors.

    iii. Motor vehicles — Vehicle & Operator Services Agency

    The road traffic and safety directorate (DSCR), receives notifications made by car manufacturers concerning vehicles and equipment sold under the manufacturer’s brand, either directly by the manufacturers themselves or through their distribution network.

    Automotive - Under Article R. 323-6 of the Code of the road, passenger cars and light trucks must follow :

    - A technical inspection within six months prior to the expiration of four years from the date of their Premiere release ;

    - Subsequent to that review, a periodic test, renewed every two years ;

    - Before any mutation occurring after the period of four years (see above), a technical inspection, which are always-ever exempt vehicles that have undergone a technical inspection within six months preceding the application date establishment of a new certificate of registration.

    In addition, the vans must be within two months before the expiry of a period of one year after each technical inspection conducted from 1 January 1999, a further technical review on the control of pollutant emissions (...).

    The technical control is provided by an auditor approved by the State exercising its functions in a control center or not attached to a control network that may incur civil liability.

    iv. Medicines and drugs Drugs can only be distributed in pharmacies and, sometimes, only on medical prescription (C. Health publ., art. L. 4211-1). The case of veterinary medicines, veterinary surgeons and only pharmacies can distribute them.

    Any rate, display or distribution of drugs is prohibited on public roads, fairs or markets, to any person bearing the same pharmacy degree (C. Health publ., art. L. 5125-27). v. Elevators Law No. 2003-590 of 2 July 2003 (Journal July 3, 2003), in Article 79, 2, incorporates the Code of the construction and housing a series of articles on security elevators installed in buildings and in particular Article L. 125-2-3 submitting lifts to a periodic test on their condition and safety of persons. This technical review is entrusted to a qualified professional in this area which has no manufacturing activity, installation or maintenance of elevators and has no ownership stake in a company engaged in such activities.

    b. Powers of authorities (samples, search, seize, notices) Different administration agents are in charge of making inquiries to search products that do not fulfill security requirement. Article L. 222-1 of the Consumer Code lists the qualified officers to undertake the review of security products and services. They are :

    - Officers of the Directorate for Competition, Consumption and Fraud Control ;
    - Service officers measuring instruments ;
    - Officers of the Directorate General of Customs and Excise ;
    - Officers of the Directorate of Quality (veterinary and food hygiene) ;
    - Doctors and public health inspectors pharmacists public health inspectors ;
    - Labor inspectors ;
    - Inspectors of classified installations ;
    - Police and gendarmerie.

    Search and visits : article L. 222-2 of the Consumer Code allows all officers to enter both day and night in location manufacturing, producing, packaging, storing, filing or sale, in vehicles for transporting goods, and in places where are kept or slaughtered animals whose meat or products are intended for human or animal (reference to Article L. 222-2, cited in Article L.213-4 of the Code. Article L. 222-2 of the Consumer Code derogates from the provisions of the Code of Criminal Procedure. Usually search and home visits can not intervene unless special circumstances, between 6 am and 21 pm (CPC, art. 59).

    These visits can take place without warning and even if the business owner is not attending. At night, the officers may enter such premises provided they are open to the public. Where premises are mixed use (office and residential), these visits must be made during the day and with the authorization of the prosecutor, if the occupant opposes to it.. The agents who carried out the checks, transmit their findings and conclusions to the State representative in the department (Prefet). It will forward the file with its reasoned opinion to the minister concerned and the Minister for Consumer Affairs. The judge or the court may order the temporary suspension of marketing the product or the provision of services under investigation. These decisions may be appealed.

    c. International enforcement – RAPEX

    Decision No. 84/133/EEC of 2 March 1984 (OJ No L 70, March 13, 1984, p. 16) establishes an organized system for exchanging information about products that may endanger the health and the safety of persons which is known as RAPEX. This system was taken in subsequent directives and in particular that of 3 December 2001 (Dir. December 3, 2001, spec. No. 6 above) in Article 10. This article reads as follows : 1. The Commission encourages the networking of European Member States’ authorities with responsibility for product safety, particularly in the form of administrative cooperation, and she participates.

    2. This networking is developing a coordinated way with other existing Community procedures, particularly RAPEX. It aims in particular to facilitate : a) exchange information on risk assessment, dangerous products, test methods and results, recent scientific developments and on other aspects to consider in monitoring activities ; b) the establishment and execution of joint surveillance and testing ; c) the exchange of expertise and best practices and collaboration in training activities ; d) improved cooperation at Community level in relation to the tracing, withdrawal and recall of products dangerous ;

    Exchange of information - When a Member State takes measures which restrict the placing of products on the market, even if it is the result of a negotiated procedure, or if it imposes the withdrawal or recall products it considers unsafe, it shall notify such measures to the Commission through the RAPEX, specifying the reasons for adopting them. He also informes the Commission of any modification or waiver of any such measure (Dir. prev., Art. 11).

    The Commission can then inform all Member States if it considers that the danger is incurred by the citizens of member countries.

    Access to RAPEX shall be open to candidate countries, third countries or international organizations, within the frame-work agreements between the Community and these countries or international organizations, on terms to be defined in these agreements. These are based on reciprocity and include provisions on confidentiality corresponding to those applicable in the Community.

    4. Appeals Recourses against administrative decisions must be brought before administrative tribunals. Judgments of first instance may in principle be appealed before the Courts of Appeal within one month from the date of the service or notification of the decision (plus two months for the appellants domiciled abroad, unless the amount of the claim brought before the first judge(s) did not exceed 4,000 Euros, in which case the appeal may only be lodged with the French Supreme Court. The Court of Appeal rules once again on the facts and on the law. The Courts of Appeal are not bound by the decision of lower judges, whether on a question of law or of fact. Decisions of Courts of Appeal can be appealed before the French Supreme Court (“Conseil d’Etat” for administrative matters and "Cour de cassation" for civil and commercial cases), in principle, in civil matters, within two months as from the date of service of the decision. The Cour de cassation either rejects the appeal or quashes the order and, generally, refers the case to a different Court of Appeal to be reviewed again.

    5. Sanctions

    A penalty fine of €1,500 shall be applied to those which disregarded a decision prohibiting :

    1 ° to manufacture, import, export, placing on the market for free or not, keep for sale or free distribution of a product or service that was subject to a suspension ;

    2 ° failing to disseminate warnings and precautions ordered ;

    3 ° not to share, not to change or not to repay all or part of the product or service, in terms of place and time prescribed ;

    4 ° not to make the withdrawal or destruction of a product.

    The fine is raised to €3,000 in the event of re-offending within one year (French Consumer’s Code art. R 223-1 and R 223-4). Forfeiture of the products can also be ordered.

    Legal entities can be applied a 7500 euros fine (15000 euros in case of re-offending)and are also punishable with forfeiture of the thing that was used to commit the offense or the product itself.

    Product Liability Note : this is only a summary 1. Potential defendants (producers, distributors etc) 2. Sources of liability a. Statute (the more important provisions) In addition to the two general systems of contract and tort liability, which are mutually exclusive, a French statute dated 19 May 1998 transposed into French law the 1985 EC Directive 85/374 on liability for defective products. It introduced a specific system of strict product liability. Pursuant to Article 13 of this Directive, this strict liability system should not affect any rights an injured person might have under "the rules of the laws, of contractual or non-contractual liability" or "a special liability system". Accordingly, Article 1386-18 of the French Civil Code provides that the strict product liability system shall exist alongside the contractual or tort liability systems. Strict product liability : the statute dated 19 May 1998 (Act No. 98-389 on liability for defective products), implementing the Directive, introduced a new title, "liability for defective products", into the French Civil Code. This set of articles has been amended by two successive statutes, a "Simplification of the Law" statute dated 9 December 2004, and a statute of 5 April 2006 (sec question 1.3). This specific system of product liability is based on strict liability. It enables an injured party to bring an action without having to prove any breach of contract, fault or negligence on the part of the producer, the cornerstone of this system being the notion of "defect". The defective product is defined by Article 1386-4 of the French Civil Code as "a product which does not provide the safety which a person is entitled to expect", taking all circumstances into account. The producer owes the same duty towards any injured party, whether a contracting party or a third party. For strict product liability to apply, the claimant must prove that the product was defective, the existence of damage (bodily injury or damage caused to property, under certain restrictions, sec question 6.2 below) and the causal link between the defect and such damage. The liability regime due to defective products was incorporated into the Civil Code (articles 1386-1 to 1386-18) by the law 98-389 of 19 May 1998, which was transposed from the community directive 85/374 of 25 July 1985, amended by the directive 99/34 of 10 May 1999.The liability established by the 1998 law is a non-fault liability, also called objective or automatic liability, which is incurred by the producer of defective products even vis-à-vis a professional, which is superposed on existing liability regime. b. Tort Tort liability constitutes an appropriate remedy (except in the particular case of chains of contracts mentioned above) when a party is seeking damages for an injury which does not result from the breach of a contractual obligation by a co-contracting party. i. Liability for fault- based upon Article 1382 of the French Civil Code Article 1382 of the French Civil Code provides that in order for a claim in tort to be successful, the claimant must prove : 1. that the defendant has been negligent, i.e., failed to behave like a "reasonable man", or breached an obligation imposed by a statute or regulation ; 2. that he or she has suffered a loss ; and 3. that there is a causal link between the two. Although there is a strict separation under French law between liability in contract and in tort, it is possible for a person who suffered damage from a breach of contract lie or she vas not privy to, to rely on such a breach in order to satisfy the first condition of Article 1382 (a negligent act or omission).

    Article 1382 of the French Civil Code applies irrespectively of the intentional breach or omission to act as a reasonable man. Moreover, an action based upon Article 1382 ma)’ be brought where there has been a breach of a statutory obligation, when such a breach causes an injury, regardless of the existence of other specific sanctions punishing such a breach in particular. ii Strict tort liability based upon Article 1384 of the French Civil Code Article 1384 provides that "one shall be liable [..] for the things that one has under its custody". Under this system of liability, no fault is required. The claimant only has to prove that his or her injury vas caused by a "thing", of which the defendant had the powers of use, control and management. As regards accidents caused by products, French case law has adapted this principle in order to hold a manufacturer or a distributor strictly liable, by considering that they have retained "custody" of the products, despite their apparent transfer to the users. This bas been applied by case law when the product, by its nature, contained a latent potential for harm (e.g., explosion of products such as televisions, gas cylinders, fire extinguishers and bottles of sparkling water or sodas). c. Contract Pursuant to the general principles of French contract law developed by case law on the basis of Articles 1134 and 1147 of the French Civil Code, the injured party may recover damages against the supplier if he or she can prove the following :
    - the supplier failed to comply with an express or implied obligation (an implied obligation is one provided b)’ law or case law, irrespective of the terms of said contract) ;
    - there is a causal link between such a failure and the injury suffered ; and ;

    - the damage suffered by the injured party was foreseeable at the time of the formation of the contract (Article 1150 of the French Civil Code). Yet, a supplier will be liable for those unforeseen and unforeseeable injuries which resulted from his fraudulent or grossly negligent behavior. The injured party may also rely on the warranty against hidden defects (Articles 1641 et seq, of the French Civil Code). Under these provisions, the seller may be held liable where a defect, which is not apparent, renders the product sold unfit for the use for which it is intended, or diminishes the usefulness of the product to such a point that the plaintiff would not have acquired it or would not have paid the agreed-upon purchase price, had he or she known of the defect. The fact that the seller was unaware of the existence of such a defect is not a valid defense. Indeed, where the supplier is a professional he is presumed to be aware of the hidden defects in the products lie sells.

    3. Claimants, class actions

    The liability regime due to defective products applies to legal action taken by victims affected on French territory, against producers established in France ; that taken against a producer established abroad is governed by the law designated either by The Hague convention of 2 October 1973, or by the set of conflicting law rules when such convention does not apply.

    Both the consumer and the professional may cite damage to their person or property, as the provisions governing the compensation for such damage do not make any distinction between these two qualities.

    The victim may claim this compensation whether or not bound by a contract with the producer of the product in circulation (French Civil Code art. 1386-1). Class action : there is no group or class action procedure under French law. However, since 2005 its possible introduction in France has been discussed. Four years later, this project is still not yet definitive. According to the latest project, class actions in France would most likely have the following features : designated consumer associations could bring actions against companies before the civil courts in cases where consumers had suffered damage because of a breach of a contractual obligation by the company ;
    -  the amount of compensation awarded to each consumer would be limited ;
    -  if the company were found liable, any consumer who had suffered a loss would be able to request compensation within a specific period of time under the "opt¬ion" system ;
    -  if the company were to refuse to compensate the plaintiffs, or did not respond to the judgment, the consumer would be able to claim compensation. The court could order the company to pay this by means of a penalty for failure to comply ; and if any action by an association vas found to be vexations or an abuse of process, the plaintiffs would be obliged to compensate the defendant for any damage that it had suffered.

    4. Causation The burden of the proof generally falls on the claimant according to Article 9 of the French Code of Civil Procedure and Article 1315 of the French Civil Code, in respect of contracts or obligations. Pursuant to this principle, an injured party must prove that the supplier of a product is al fault, that he or she has suffered a legally recognised injury and that there is a causal link between the fault of the supplier and the damage suffered. However, in certain fields, the defendant may have to rebut the presumption that he or she is at fault. For example, a supplier of a product may be presumed to be at fault if he or she failed to respect his obligation to warn the injured party of the inherent dangers of the product. In other cases, such as under strict tort liability based upon Article 1384 of the French Civil Code, the third party injured by a product does not even have to prove the fault of the supplier of such product, as long as the supplier is deemed to have retained control over the product.

    Failure to warn may give rise to liability on different grounds. The intensity of the obligation of information and the burden of the proof regarding the delivery of the information will vary depending on the knowledge and quality of the parties in presence. Lack of information may give rise to liability based on either tort, should the information have to be given before the conclusion of the contract (i.e., information which may influence the other party’s decision to conclude the contract, such obligation sometimes being provided for by the law, e.g., Articles L.111-1 to L.111-3 of the French Consumer Code), or on the ground of contractual liability, if the information should have been given during its performance (e.g., information of the user as to the manner in which the product is to be employed and which is necessary to use the product properly and accomplish the task for which it was designed). The obligation to warn comes into play whenever the supplier or the seller has a particular technical or professional expertise relating to the product to be sold or when the party with whom he deals is so inexperienced or incompetent that he would be unable to obtain such information himself. The fact that a particular product may not appear harmful to the supplier does not discharge the latter’s obligation to warn the purchaser or the user. According to case law, a smoker is supposed to be aware of the harmful effects associated with the consumption of tobacco, as such information is common and widespread social knowledge. Therefore, smokers cannot expect the manufacturer to assume responsibility for the damages caused ho their health by tobacco (French Supreme Court, 8 November 2007, considering that the smoker could not have remained unaware of the dangers of smoking).

    5. Remedies for injury/damage, and consequential loss (measures of compensation)

    As the term “damage” is not subject to any restriction, the victim can claim compensation for all losses he sustains, both tangible and intangible. French law recognises two types of damage : physical damage ("dommage matériel") ; and non-physical damage ("dommage moral"). Physical damage is that which is caused to the person (e.g., bodily injury) or property of the injured person. Non-physical damage includes the pain and suffering of the injured party, the loss of enjoyment, the aesthetic injuries, the damage caused to the honour or emotions of the injured party (e.g., slander or the mental suffering resulting from the death of a spouse). The loss of an opportunity to obtain a future benefit may also give rise to an award for damages if the court finds that the injured party had a good chance of obtaining such a benefit. Under the strict product liability system, pursuant to Article 1386-2 of the French Civil Code, the recoverable damages are the damages caused by the defective product to the victim itself (i.e., death or personal injury) and to goods (other than the defective product itself) irrespective of whether the said goods are used for private or professional purposes.

    Whereas, under the 1985 EC Directive, the Member States could set a ceiling on the producer’s liability for bodily damage, France has chosen not to do so.

    6. Procedure, limitation, funding, costs Procedure : products liability cases are usually heard by Civil or commercial Courts, which are exclusively composed of professional judges. Victims can also ask for damages before the criminal Courts. Under French law, there are no expert assessors who assist the judges and sit with them in court. However, judges may personally check the facts in question and can be assisted by technicians.

    The right to compensation for damage due to the defective product expires ten years after the product is launched for circulation unless the victim has claimed compensation (French Civil Code art. 1386-16). At the end of this period, action may still be taken against the producer, but in the terms of common law on liability.

    Within the period of ten years, the action becomes invalid within a period of three years from the date on which the claimant becomes or should have become aware of the damage, the defect and the identity of the producer (French Civil Code art. 1386-17).

    The supplier (seller or leaser) against whom legal action is taken by the victim of the damage and who brings the producer into the case must act in the year following the date on which against is taken against it (French Civil Code art. 1386-7, para. 2).

    Exemption - Limitation : The producer is exempt from liability if it proves one of the following facts (French Civil Code art. 1386-11) :

    - that it had not launched the product for circulation ;
    - that, in view of the circumstances, it shall be considered that the failing having caused the damages did not exist when the product was launched for circulation by it or that this failing originated at a later time ;
    - that the product was not intended for sale or any other form of distribution ;
    - that the state of scientific and technical knowledge, at the time when it launched the product for circulation, did not make it possible to detect the existence of the defect (see Toulouse Court of Appeal 22-2-2000 : JCP G 2000 II n° 10429 note Ph. Le Tourneau for an example of a detectable defect) ;

    Clauses that exclude or limit liability : Clauses which exclude or limit liability due to defective product are prohibited and shall be deemed not be written (French Civil Code art. 1386-15, para. 1).

    However, they are valid between persons acting in a professional capacity provided that they only concern damages caused to goods not principally used by the victim for private consumption or use (French Civil Code art. 1386-15, para. 2).

    The damages excluded should be understood as all losses that may result from the danger to the goods since the victim is entitled to compensation for all losses ; the exclusion cannot therefore be limited to material losses on the grounds that in this the law did also not cover “damage resulting from a danger” but the “damages caused to the goods”.

    Costs : One must here distinguish between Court fees, other incidental expenses, i.e. the procedural costs which are strictly necessary to pursue the suit ("dépens"), and the other expenses incurred by a party in respect to the dispute. Pursuant to Article 696 of the French Code of Civil Procedure, the successful party may be able to recover ail the procedural costs ("dépens") listed at Article 695 of the French Code of Civil Procedure (e.g., the necessary translation costs, the court appointed experts’ fees, the witnesses’ expenses and die counsels’ fees (when their intervention is required by law, such as the "Avoués" who represent the parties before the Court of Appeal, and only up to the amount fixed by Decree).

    Any other legal costs incurred by a party, such as the legal fees when they are freely determined between the lawyer and his or her client, fall under the scope of Article 700 of the French Code of Civil Procedure.

    According to this text the judge may order that the losing party shall pay to the other a sum of money which corresponds to the costs incurred which are not included in the procedural costs. The judge takes into consideration equity or the economic position of the sentenced party. In this respect, the recoverable amounts will be determined on a case-by-case basis.

    Source : Granrut Avocats