Advertising

Laws against misleading advertisements differ widely from Member State to Member State.  To respond to this issue in the internal market, the Commission adopted a directive, in force since October 1986, to establish minimum and objective criteria regarding truth in advertising.  Under the Directive, misleading advertising is defined as any “advertising which in any way, including its presentation, deceives or is likely to deceive the persons to whom it is addressed or whom it reaches and which, by reason of its deceptive nature, is likely to affect their economic behavior or which for those reasons, injures or is likely to injure a competitor.”  Member States can authorize even more extensive protection under their national laws.  The Directive was amended in October 1997 to include comparative advertising.  Comparative advertising, subject to certain conditions, is defined as “advertising which explicitly or by implication identifies a competitor or goods or services of a competitor.” Member States can, and in some cases have, restricted misleading or comparative advertising.  The Digital Services Act also includes provisions on advertising.  It bans targeted advertising for children by online platforms, as well as targeted advertising based on sensitive data such as sexual orientation, religion, and ethnicity.  The Digital Markets Act foresees that combining personal data for targeted advertising will only be allowed with explicit consent to the gatekeeper.

The European Union’s Audiovisual Media Services (AVMS) Directive establishes legislation on broadcasting activities allowed within the European Union.  Since 2009, the rules allowing for U.S.-style product placement on television with exceptions.  AVMS was revised to extend the scope of the Directive to video-sharing platforms and social media in some circumstances.  For example, children’s programming is subject to a code of conduct that includes a limit on junk food advertising to children, but organizations subject to the AVMS Directive are encouraged to do more to protect children.  Following the adoption of the 1999 Council Directive on the Sale of Consumer Goods and Associated Guarantees, product specifications, as laid down in advertising, are considered legally binding on the seller.

In addition, the European Union adopted Directive 2005/29/EC concerning fair business practices in a further attempt to tighten consumer protection rules.  These rules outlaw several aggressive or deceptive marketing practices such as pyramid schemes, liquidation sales when a shop is not closing down, and artificially high prices as the basis for discounts in addition to other potentially misleading advertising practices.  Certain rules on advertising to children have also been established.

Medicines

The advertising of medicinal products for human use is regulated by Council Directive 2001/83/EC, as amended by Directive 2004/27/EC.  The advertising of medicinal products is forbidden if market authorization has not yet been granted or if the product in question is a prescription drug.  Mentioning therapeutic indications where self-medication is not suitable is not permitted, nor is the distribution of free samples to the general public.  The text of the advertisement should be compatible with the characteristics listed on the product label and should encourage rational use of the product.  The advertising of medicinal products destined for professionals should contain essential characteristics of the product as well as its classification.  Inducements to prescribe or supply a medicinal product are prohibited, and the supply of free samples is restricted.

General principles included in the Code for Human Medicines Directive include:

• Drugs that are not authorized cannot be advertised to any person (including the medical profession).
• Prescription-only drugs and drugs containing ingredients that are psychotropic or narcotic must not be advertised to the public.
• All permitted advertising must conform to the summary of product characteristics.
• All permitted advertising must encourage rational use and must not be misleading.
• Member States can choose to ban the advertising to the public of drugs that are reimbursed.
• Companies must establish their own scientific service.  They must retain copies of advertisements published and must provide those to the authorities on request.

In addition to the directives and regulations that relate specifically to the pharmaceutical industry, these directives and regulations apply:

• Directive 2005/29/EC concerning unfair business-to-consumer commercial practices in the internal market, which regulates advertising to consumers.
• Directive 2006/114/EC concerning misleading and comparative advertising.
• Council Directive 2010/13/EU concerning the provision of audio-visual media service.
• Regulation No 2006/2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws, as amended by Directive 2015/2302 and Regulation 2017/2394 on cooperation between national authorities responsible for the enforcement of consumer protection laws.

In addition, companies operating in the European Union should refer to applicable codes of practice, in particular the European Federation of Pharmaceutical Industries and Associations Code and the Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organizations.

Nutrition and Health Claims

On July 1, 2007, Regulation 1924/2006 on nutrition and health care claims set EU-wide conditions for the use of nutrition claims such as “low fat” or “high in vitamin C” and health claims such as “helps lower cholesterol.”  The regulation applies to any food or drink product produced for human consumption that is marketed in the European Union.  Only foods that fit a certain nutrient profile (below certain salt, sugar, and/or fat levels) can carry claims.  Nutrition and health claims are only allowed on food labels if they are included in one of the European Union’s positive lists.  Food products carrying claims must comply with the provisions of nutritional labeling Directive 90/496/EC and its amended version, Directive 1169/2011.

In December 2012, a list of approved functional health claims went into effect.  The list includes generic claims for substances other than botanicals.  Disease risk reduction claims and claims referring to the health and development of children require authorization on a case-by-case basis, following the submission of a scientific dossier to the European Food Safety Authority.  Health claims based on new scientific data must be submitted to the European Food Safety Authority for evaluation, but a more simplified authorization procedure has been established.

Nutrition claims, in place since 2006, can fail one criterion: i.e., if only one nutrient (salt, sugar, or fat) exceeds the limit of the profile, a claim can still be made provided the high level of that particular nutrient is clearly marked on the label.  For example, a yogurt company can make a low-fat claim even if it has high sugar content but only if the label clearly states, “high sugar content.”  A European Union Register of nutrition claims has been established and is updated regularly.  Health claims, however, cannot fail any criteria.

As part of the EU Green Deal, in May 2020, the Commission announced that it would set nutrient profiles to restrict promotion of food high in salt, sugars, and/or fat as required by Regulation 1924/2006 before the end of 2022.  Currently, the implementation of this Regulation concerning nutrition and health claims made on foods remains incomplete since the Commission did not establish nutrient profiles that had to be set by January 2009.  In that context, nutrient profiles are thresholds of nutrients such as fat, sugars, and salt above which nutrition and health claims are restricted or prohibited.  This proposal builds on the results of the European Union’s Regulatory Fitness and Performance Programme (also known as REFIT) evaluation of EU legislation on nutrition and health claims launched in 2015.  Detailed information on the EU’s Nutrition and Health Claims policy can be found on the USEU/FAS website and in the website detailing USDA Food and Agricultural Import Regulations and Standards EU 28 2020.

Food Information to Consumers

The standard U.S. label does not comply with the EU’s labeling requirements.  On December 13, 2014, the EU’s new Food Information to Consumers (FIC) Regulation 1169/2011 became applicable and introduced new obligations and changes to the existing rules.  Detailed information on the new labeling requirements can be found in the GAIN report “How to comply with the EU’s new food labeling rules” and the GAIN report “New EU food labeling rules published.”

Food Supplements

Directive 2002/46/EC harmonizes the rules on labeling of food supplements and introduces specific rules on vitamins and minerals in food supplements.  Ingredients other than vitamins and minerals are still regulated by Member States.

Regulation 1925/2006 harmonizes rules on the addition of vitamins and minerals to foods.  The regulation lists the vitamins and minerals that may be added to foods.  A positive list of substances other than vitamins and minerals has not been established yet, although it is being developed.  Until then, Member State laws will govern the use of these substances.

Tobacco

The Tobacco Advertising Directive (2003/33/EC) bans tobacco advertising in printed media, radio, and on the Internet, as well as the sponsorship of cross-border events or activities.  Advertising in cinemas and on billboards or merchandising is allowed, though these are banned in many Member States.  Tobacco advertising on television has been banned in the European Union since 1989 and is governed by the AVMS Directive.  A 2016 revision to the legislation includes the requirement for bigger, double-sided health pictorial warnings on cigarette packages and possibility for plain packaging along with health warnings, tracking systems.

Consumer Issues

Introduction

Conscious of the discrepancies among Member States in product labeling, language use, legal guarantee and liability, the redress of which inevitably frustrates consumers in cross-border shopping, European Union institutions have launched a number of initiatives aimed at harmonizing national legislation.  Suppliers within and outside the European Union should be aware of regulation affecting sales, service, and customer support.

Product Liability

Under the 1985 Directive on Liability of Defective Products, amended in 1999, the producer is liable for damage caused by a defect in their product.  The victim of the wrongdoing must prove the existence of the defect and a causal link between defect and injury (bodily as well as material).  A reduction of liability of the manufacturer is granted in cases of negligence on the part of the victim.

On September 28, 2022, the European Commission published its proposal for a new directive revising the existing law.  On December 14, 2023, the Council and European Parliament reached provisional agreement on the revision.  The law will update existing product liability rules adopted in 1985 to address modern digital features and advances in the circular economy.  The new rules ease the burden of proof for the person requiring compensation, allow for broader discovery so that an injured person can request access to relevant evidence at the disposal of the manufacturer in order to be able to prove their claim, and provide for compensation for both material losses and non-material losses in so far as they are compensable under national law.  Once formally approved, the legislation will enter into force, and the new rules will apply to products placed on the market 24 months after entry into force of the directive.

Product Safety

The 1992 General Product Safety Directive (GPSD) introduced a general safety requirement at the EU level to ensure that manufacturers only place safe products on the market.  It was revised in 2001 to include an obligation on the producer and distributor to notify the Commission in case of a problem with a given product, provisions for its recall, the creation of a European Product Safety Network, and a ban on exports of products to third countries that are not deemed safe in the European Union.

In 2020 the European Commission announced its intention to revise the aging General Product Safety Directive following an evaluation of the current system.  Following a round of public consultations in 2020, the Commission published its proposal for a revision of the Directive in June of 2021.  The new General Product Safety Regulation entered into force in June 2023, and it will replace the General Product Safety Directive as from December 13, 2024.  Amongst other things, the new General Product Safety Regulation updated the EU general product safety framework to reflect technological progress, to ensure better enforcement, and to improve the recall process of dangerous products.  Importantly, the new Regulation extended the obligation for all non-harmonized products imported into the European Union to have an economic operator in the EU responsible for product safety issues, expanded the list of key elements to assess the safety of products, reinforced the product traceability requirements, and established specific product safety requirements for online marketplaces. 

Legal Warranties and After-Sales Service

Under the 1999 Directive on the Sale of Consumer Goods and Associated Guarantees, professional sellers are required to provide a minimum two-year warranty on all consumer goods sold to consumers (natural persons acting for purposes outside their trade, businesses, or professions), as defined by the Directive.  The remedies available to consumers in case of non-compliance are repair of the good or goods, replacement of the good or goods, a price reduction, and cancellation of the sales contract.

For more information on this topic, please consult the Commerce Department’s consult the Department of Commerce’s Country Commercial Guides for individual Member States.

Local Professional Services

For information on professional services located within each Member States, please consult the relevant 

Member States’ Country Commercial Guide.  In addition, the relevant American Chamber of Commerce serves as a business association that engages with the relevant Member State, or in the case of the European Union, the American Chamber of Commerce to the European Union.