Glossary of Common Terms Used in EU Product Safety
Robert Hinchliffe from Intertek decodes EU compliance terminology
Accreditation: procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out speciﬁc tasks.
CE: European Conformity marking required under New Approach directives but not under General Product Safety Directive. Comprises a small mark depicting ‘CE’ usually applied on consumer products without any mandatory third party testing.
Certiﬁcation: procedure by which a third party gives written assurance that a product, process or service conforms to speciﬁed requirements.
Conformity assessment: Any activity concerned with determining directly or indirectly that relevant requirements are fulﬁlled.
Essential Requirements: Requirements that represent the core of European Union law around which an effective policy has been developed in matters of safety, health and other measures for those areas covered by the ‘new approach directives’.
European Directive: A legislative instrument within the European Union that is binding for Member States with regards to the objectives to be achieved. It is however left to the national authorities to choose the form and methods to be used within their own legal systems to attain the objectives that were agreed on at the European Union level.
Global Approach: Policy adopted by European Union with respect to conformity assessment and certiﬁcation.
Harmonised Standard: European standard whose reference has been published in the Ofﬁcial Journal of the European Communities. Such a standard gives presumption of conformity under so-called New Approach legislation and shortly will also under the General Product Safety Directive.
Hazard: The intrinsic property of the agent, which makes it capable of causing adverse effects to occur in humans or the environment, under speciﬁc conditions of exposure.
New Approach Directive: Directives that have been put into force since May 1985 by the Council of the European Communities which deﬁne legislative harmonisation in those sectors where barriers to trade are created by justiﬁed divergent national regulations concerning the health and safety of citizens and consumer and environmental protection, will be conﬁned to laying down the ‘essential requirements’, conformity with which will entitle a product to free movement within the Community.
Precautionary Approach: An approach to risk management decision-making that is applied in circumstances of scientiﬁc uncertainty, reﬂecting the need to take action in the face of a potentially serious risk without awaiting the results of scientiﬁc research. Cost-effective action must be taken when there are threats of serious or irreversible damage to human health, even if some cause and effect relationships are not fully established scientiﬁcally.
Presumption of Conformity: Assumption made failing proof to the contrary, based on known facts, of the fulﬁlment by a product, process or service of speciﬁed requirements.
REACH: REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation & restriction of Chemicals.
RoHS: The Restriction of the Use of Certain Hazardous Substances (RoHS) in Electrical and Electronic Equipment (EEE). This legislation bans the placing on the EU market of new EEE containing more than the agreed levels of:
- lead (Pb)
- cadmium (Cd)
- mercury (Hg)
- hexavalent chromium (Cr6+)
- polybrominated biphenyls (PBB)
- polybrominated diphenyl ethers (PBDE)
Safeguard Clause: Clause contained in European regulation whereby national authorities have the right to challenge whether a particular European standard should give a legal presumption of conformity with the appropriate European regulations.