An Overview of European Products Regulation
The regulation of products is extensively governed by legislation that operates on a European Union-wide level. While it can be a complex and sometimes onerous regulatory system, it brings some important benefits for product manufacturers. First, the regimes, for the most part, provide clear guardrails to help companies design products with confidence that, if the rules are complied with, will be acceptable to be marketed. Second, compliance with the rules potentially opens the door for the same product to be sold in 27 or more countries – without further testing or design changes needed.
Some product categories are governed by sector-specific (vertical) measures. Many of the sector-specific regimes are those that require the products to carry the CE marking, which serves as the manufacturer’s declaration that the product complies with all the requirements of the applicable European regulatory regime. To the extent that consumer products are not covered by vertical measures, they will be subject to horizontal measures under Directive 2001/95/EC on general product safety – the General Product Safety Directive (GPSD). Under the GPSD, a “product” is any product, including in the context of providing a service, which is:
- Intended for consumers, or that is reasonably foreseeable to be used by consumers, whether intended for them or not.
- Supplied or made available, for free or not, in the course of a commercial activity.
- New, used or reconditioned.
Examples of vertical sector-specific measures include directives and regulations governing the safety of:
- Low-voltage electrical equipment
- Personal protective equipment
- Radio equipment
- Motor vehicles
- Medical devices
- Equipment for use in explosive atmospheres
Other relevant horizontal measures include:
- Regulation (EC) 1907/2006 on the registration, evaluation, authorization and restriction of chemicals (REACH Regulation), which addresses the production and use of chemical substances in the EU.
- Regulation (EC) 1272/2008 on the classification, labeling and packaging of substances and mixtures (CLP Regulation), which incorporates the classification and labelling criteria agreed upon at the United Nations, and requires manufacturers to appropriately classify, label and pack products that contain dangerous substances and mixtures before placing them into the consumer market.
- Directive 2012/19/EU on waste electrical and electronic equipment (recast WEEE Directive), which regulates waste electrical and electronic equipment (WEEE) and provides for the creation of collection schemes where consumers can return such equipment free of charge.
- Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast RoHS Directive), which governs the restriction on use of certain hazardous substances in electrical and electronic equipment.
- Regulation (EU) 1007/2011 on textile fiber names and related labelling and marking of the fiber composition of textile products (Textiles Regulation), which regulates fiber names and related labelling requirements for textile products.
For the most part, these regimes are enforced at a national level, and are therefore subject to some degree of differences in interpretation and enforcement. There also will be some limited requirements that arise from national laws in Europe, such as translations into the local language.
The European product regulatory regime is dynamic, and changes are frequent.