There is a broad array of EU legislation pertaining to the marking, labeling, and packaging of products in the European Union. The first step in investigating the marking, labeling, and packaging legislation that might apply to a product entering the European Union is to draw a distinction between what is mandatory and what is voluntary. Decisions related to mandatory marking, labeling, or packaging requirements may sometimes be left up to individual Member States. Furthermore, voluntary marks and labels are used as marketing tools in some Member States but not in others. This section is focused primarily on the mandatory marks and labels seen most often on consumer products and packaging, which are typically related to public safety, health, or environmental concerns. It also includes a brief overview of a few mandatory packaging requirements, as well as more common voluntary marks or labels used in EU markets.
It is also important to distinguish between marks and labels. A mark is a symbol and/or pictogram that appears on a product or its respective packaging. These range in scope from signs of danger to indications of methods of proper recycling and disposal. The intention of such marks is to provide market surveillance authorities, importers, distributors, and end users with information concerning safety, health, energy efficiency and environmental issues relating to a product. Labels, on the other hand, appear in the form of written text or numerical statements, which may be required but are not necessarily universally recognizable. Labels typically indicate more specific information about a product, such as measurements or an indication of materials that may be found in the product (such as in textiles or batteries).
Mandatory Marks and Labels
- Dangerous substances
- Electrical and electronic equipment
- Energy efficiency
- Explosive atmosphere
- Food related
- Household Appliances
- Measuring instruments
- Noise Emissions
- Recycling; separate collection
- Tire labeling
- Units of measurement
- Wood packaging
Voluntary Marks and Labels
- Materials in contact with food
- The Green Dot
- Recycling marks
Voluntary and mandatory marks and labels apply to all EU Member States, countries in the European Economic Area, European Free Trade Association, as well as candidate countries seeking membership to the European Union.
Updated Medical Device Regulations
The EU’s revised Medical Device Regulation went into effect in May 2021. The revised In Vitro Diagnostic Device Regulation is set to go into effect in May 2022 (although an extension is being sought on the grounds that the European Union has not named a sufficient number of notified bodies to meet the demand for certifications caused by this regulation). In addition, restrictions put into place due to the COVID-19 pandemic have prevented many audits from taking place to certify device requirements under the Medical Device Regulation. The European Commission has published an official notice allowing notified bodies to conduct initial audits of medical device quality management systems virtually, which includes audits of manufacturers’ suppliers and subcontractors to verify their manufacturing and other processes, but this applies to the Medical Device Regulation and not the In Vitro Diagnostic Device Regulation.
Updated Machinery Regulation
In April 2021, the Commission released a Proposed Regulation for the Safety of Machinery to replace the current Machine Safety Directive, which has been in effect since 2006. Machinery in the European Union is broadly defined as consisting of an assembly of components, at least one of which moves, for a specific application. The drive system of machinery is powered by energy other than human or animal effort. The new Machine Safety Regulation could be adopted sometime by 2023 but the European Parliament has not adopted a position on this draft regulation. One of the features of the new regulation is that it discusses the place of, and safety requirements for, artificial intelligence in machinery.
For more information on EU labeling and marking requirements, Visit the European Union country Commercial guide article at https://www.trade.gov/country-commercial-guides/eu-labelingmarking-requirements.