EU product compliance glossary

This glossary explains the key terms and abbreviations that manufacturers, importers and distributors encounter when placing products on the European Union market. Each entry gives the regulatory term, the applicable EU legislation where relevant, and a short practical explanation of what the term means for businesses operating in or selling into the EU through the Netherlands.

The glossary is maintained by MAAK Advocaten's product compliance practice, led by Martin Krüger. For Dutch legal terms in a broader context (contract law, litigation, corporate law), see our glossary of Dutch legal terms.

A

Aangemelde instantie — see Notified body.

Authorised representative (gemachtigde). A natural or legal person established in the EU who has been appointed by a manufacturer outside the EU to act on its behalf in relation to certain obligations under EU product legislation, such as holding technical documentation available for authorities and cooperating with market surveillance. Required under Regulation (EU) 2019/1020 for products where no importer is established in the EU. See product compliance law firm.

B

Blue Guide. The European Commission's guidance document on the implementation of EU product rules, formally titled "The Blue Guide on the implementation of EU product rules." Not legally binding but widely used by manufacturers, notified bodies and market surveillance authorities as the practical reference for interpreting the New Legislative Framework. Available on the European Commission's website.

C

CE marking (CE-markering). A marking affixed to a product by or under the responsibility of the manufacturer, indicating that the product complies with the applicable EU harmonised legislation. CE marking is not a quality mark and is not issued by an authority. It is a legal declaration by the manufacturer. Products that require CE marking cannot be placed on the EU market without it. See product compliance law firm.

CLP Regulation (Regulation (EC) 1272/2008). The EU regulation on Classification, Labelling and Packaging of substances and mixtures. Implements the UN Globally Harmonized System (GHS) in the EU. Applies to chemicals, not to finished products as such, but relevant for products containing hazardous substances.

Conformity assessment (conformiteitsbeoordeling). The process by which a manufacturer (or a notified body, where required) evaluates whether a product meets the essential requirements of the applicable EU legislation. The assessment follows one or more conformity assessment modules (A through H1), ranging from internal production control (module A) to full quality assurance with type-examination (modules B+D, B+F, H1). The applicable module is specified in each directive or regulation.

Conformity assessment modules. Standardised procedures (modules A, A1, A2, B, C, C1, C2, D, D1, E, E1, F, F1, G, H, H1) defined in Decision 768/2008/EC. Module A (internal production control) is the simplest and most common; modules involving a notified body (B+C, B+D, B+F, H1) apply to higher-risk products. The applicable module(s) are specified in the product-specific directive or regulation.

Construction Products Regulation (CPR) (Regulation (EU) 305/2011). The EU regulation for products permanently incorporated in construction works. Uses a Declaration of Performance (DoP) and CE marking based on harmonised technical specifications, with a different structure from the New Legislative Framework directives.

Corrective action (corrigerende maatregel). Any measure taken by an economic operator or required by a market surveillance authority to bring a non-compliant product into compliance, withdraw it from the market, or recall it from end users. Corrective actions must be proportionate to the risk and are recorded in the Safety Gate/RAPEX system when they involve serious-risk products.

D

Declaration of Conformity (DoC) (EU-conformiteitsverklaring). A formal document drawn up by the manufacturer (or authorised representative) stating that the product complies with the applicable EU legislation. Must identify the product, list the applicable directives and regulations, reference the harmonised standards or other technical specifications applied, and be signed by a responsible person. Must accompany the product or be made available to authorities on request.

Distributor (distributeur). Under EU product law, any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the market. Distributors must act with due care: verify that the product bears the required markings and is accompanied by the required documents, and not make a product available if they know or should know it does not comply. See product compliance law firm.

E

Economic operator (marktdeelnemer). A collective term in EU product law for the manufacturer, authorised representative, importer, distributor, fulfilment service provider, and (under recent legislation) online marketplace. Each economic operator has specific obligations under the applicable product legislation. Regulation (EU) 2019/1020 requires that at least one economic operator established in the EU is responsible for compliance tasks. See product compliance law firm.

EMC Directive (Directive 2014/30/EU). The EU directive on Electromagnetic Compatibility. Requires that electrical and electronic equipment does not generate electromagnetic disturbance exceeding a level that prevents other equipment from functioning, and has adequate immunity to disturbance. CE marking required.

Essential requirements (essentiële eisen). The health, safety, environmental and consumer protection objectives that a product must meet under the applicable EU harmonised legislation. Set out in the annexes to each directive or regulation. Compliance can be demonstrated by applying harmonised standards (which give a presumption of conformity) or by other means.

F

Fulfilment service provider. A natural or legal person offering warehousing, packaging, addressing and dispatching of products without having ownership of them. Under Regulation (EU) 2019/1020, fulfilment service providers can qualify as the responsible economic operator established in the EU when no manufacturer, importer or authorised representative is present.

G

GPSR (General Product Safety Regulation, Regulation (EU) 2023/988). The EU baseline safety regulation for consumer products, applicable from 13 December 2024. Replaces the General Product Safety Directive (2001/95/EC). Sets the general safety obligation, expands economic operator responsibilities, introduces specific obligations for online marketplaces, and strengthens recall and corrective action rules. Applies to products not covered by sector-specific EU harmonised legislation. See product compliance law firm.

H

Harmonised standard (geharmoniseerde norm). A European standard (EN) developed by CEN, CENELEC or ETSI at the request of the European Commission, and referenced in the Official Journal of the EU. Application of a harmonised standard gives a legal presumption of conformity with the essential requirements it covers. The manufacturer may choose not to follow the harmonised standard, but must then demonstrate conformity with the essential requirements by other means.

I

Importer (importeur). Under EU product law, any natural or legal person established in the EU who places a product from a third country (non-EU manufacturer) on the Union market. The importer must verify that the manufacturer has carried out the conformity assessment, that the technical documentation is available, that the product bears the required markings, and that the manufacturer's name and address appear on the product. The importer must also indicate its own name and postal address on the product. See product compliance law firm.

L

Low Voltage Directive (LVD) (Directive 2014/35/EU). The EU directive covering electrical equipment designed for use with a voltage rating between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current. Requires CE marking based on internal production control (module A).

M

Machinery Regulation (Regulation (EU) 2023/1230). The new EU regulation on machinery and related products, replacing the Machinery Directive (2006/42/EC) from 20 January 2027. Covers machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes, webbing and removable mechanical transmission devices. Introduces new requirements for digital technologies and cybersecurity aspects. See product compliance law firm.

Manufacturer (fabrikant). Under EU product law, any natural or legal person who manufactures a product, or has a product designed or manufactured, and markets it under its own name or trademark. The manufacturer bears primary responsibility for the conformity assessment, technical documentation, CE marking and post-market surveillance obligations. A non-EU manufacturer selling directly to the EU market must appoint an authorised representative or ensure an importer fulfils the EU-presence requirement.

Market surveillance (markttoezicht). The activities carried out and measures taken by national authorities to ensure that products on the EU market comply with applicable legislation and do not endanger health, safety or other aspects of public interest. In the Netherlands, the primary authority is the NVWA. The EU framework is set by Regulation (EU) 2019/1020. See product compliance law firm.

Medical Devices Regulation (MDR) (Regulation (EU) 2017/745). The EU regulation governing medical devices, applicable from 26 May 2021. Establishes a classification-based conformity assessment system with mandatory involvement of notified bodies for higher-risk devices.

N

New Legislative Framework (NLF). The EU policy framework for the marketing of products in the internal market, established by Regulation (EC) 765/2008, Decision 768/2008/EC and Regulation (EU) 2019/1020. Provides the common structure for EU product directives and regulations: definitions of economic operators, conformity assessment modules, CE marking rules, market surveillance and safeguard procedures.

Notified body (aangemelde instantie). An organisation designated by an EU Member State to carry out third-party conformity assessment tasks under specific EU harmonised legislation. Notified bodies assess products that fall into higher-risk categories requiring independent verification. They are "notified" to the European Commission and listed in the NANDO database.

NVWA (Nederlandse Voedsel- en Warenautoriteit / Netherlands Food and Consumer Product Safety Authority). The primary Dutch market surveillance authority for consumer product safety, food safety and many sector-specific EU product frameworks. Handles enforcement actions including requests for technical documentation, test purchases, withdrawal orders, recall orders and administrative fines. See product compliance law firm.

O

Online marketplace obligations. Under the GPSR (Regulation (EU) 2023/988), online marketplaces have specific obligations including cooperation with market surveillance authorities, internal compliance processes, takedown procedures for unsafe products, and information provision to consumers. These obligations are new compared to the previous GPSD and apply from 13 December 2024.

P

Placing on the market (in de handel brengen). The first making available of a product on the EU market. This is the regulatory trigger for most EU product compliance obligations: the product must be compliant at the moment it is placed on the market. A product is placed on the market when it is made available for the first time, whether by sale, donation, or any other form of supply in the course of a commercial activity.

Post-market surveillance (toezicht na het in de handel brengen). The systematic activities carried out by the manufacturer (and in some cases the importer) to monitor the safety and compliance of products already placed on the market. Includes collecting user feedback, monitoring incidents, tracking regulatory developments, and taking corrective action where non-compliance or safety issues are identified.

Product liability (productaansprakelijkheid). Strict liability of the manufacturer (and in some cases the importer) for damage caused by a defective product. Currently governed in the EU by the Product Liability Directive (85/374/EEC), to be replaced by the new Product Liability Directive (2024/2853) from 9 December 2026, which expands coverage to digital products, software and AI systems. See product compliance law firm.

Product traceability (traceerbaarheid). The ability to trace a product through the supply chain from manufacturer to end user. EU product legislation requires economic operators to maintain records of their suppliers and, where applicable, of the economic operators to whom they have supplied products. Traceability information must be available to market surveillance authorities on request.

R

Radio Equipment Directive (RED) (Directive 2014/53/EU). The EU directive covering equipment that intentionally emits or receives radio waves for communication or radio determination purposes. Covers a broad range of products including Wi-Fi devices, Bluetooth equipment, mobile phones, drones with radio control, and IoT devices. CE marking required.

RAPEX / Safety Gate. The EU rapid alert system for dangerous non-food products. National market surveillance authorities (including the NVWA) notify the European Commission through Safety Gate when a product presenting a serious risk is found on the market and corrective action is taken. Notifications are published on the Safety Gate website and are accessible to all EU authorities and the public.

REACH (Regulation (EC) 1907/2006). The EU regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. Applies to substances manufactured in or imported into the EU in quantities of one tonne or more per year. Relevant for product compliance when products contain substances of very high concern (SVHC) above 0.1% w/w, triggering information duties down the supply chain.

Recall (terugroepactie). A corrective measure aimed at retrieving a product that has already reached end users. Can be voluntary (initiated by the economic operator) or mandatory (ordered by a market surveillance authority). Triggers obligations towards authorities, downstream operators and end users, and raises cost-sharing questions between manufacturer, importer and distributor. See product compliance law firm.

Risk assessment (risicobeoordeling). The systematic evaluation of the risks posed by a product to health and safety. Required as part of the conformity assessment process and as part of post-market surveillance. The European Commission's risk assessment guidelines provide a methodology for determining risk level (serious, high, medium, low) based on the severity and probability of harm.

RoHS (Directive 2011/65/EU). The EU directive on the Restriction of Hazardous Substances in electrical and electronic equipment. Restricts the use of lead, mercury, cadmium, hexavalent chromium, PBB and PBDE (and, since 2019, four phthalates) in EEE. CE marking required, with a specific declaration of conformity for RoHS compliance.

S

Serious risk (ernstig risico). A risk level classification used in EU market surveillance. A product presenting a serious risk requires rapid corrective action by the economic operator and notification to the European Commission through the Safety Gate / RAPEX system. The classification is based on the combination of severity and probability of harm, assessed according to the European Commission's risk assessment guidelines.

T

Technical documentation (technisch dossier / technische documentatie). The file compiled by the manufacturer demonstrating that the product meets the essential requirements of the applicable EU legislation. Must cover the design and manufacture of the product, include risk assessments, test reports, calculations, and descriptions of the conformity assessment procedure followed. Must be kept available for national authorities for a defined period (typically ten years) after the product was last placed on the market. See product compliance law firm.

Toy Safety Directive (Directive 2009/48/EC). The EU directive on the safety of toys, covering products designed or intended for use in play by children under 14 years of age. Sets essential safety requirements for physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity. CE marking required. A new Toy Safety Regulation is under development.

Type-examination (EU type-examination) (EU-typeonderzoek). Conformity assessment module B: the part of a conformity assessment procedure in which a notified body examines the technical design of a product (or a representative sample) and verifies that it meets the applicable essential requirements. The result is an EU type-examination certificate. Usually followed by a production-phase module (C, D, E or F).

W

Withdrawal (uit de handel nemen). A corrective measure aimed at preventing a product that is already in the supply chain from being made available on the market. Distinct from recall (which targets products already in the hands of end users). Withdrawal is typically the first step when a non-compliance or safety issue is identified, and can be followed by a recall if the product has already reached consumers.

Related pages: Product compliance law firm, Glossary of Dutch legal terms, International trade law firm, Purchase agreement lawyer, Distribution agreement lawyer.

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