Glossary

Recipient of a product : means an industrial or professional user, or a distributor, being supplied with an product but does not include consumers;

Recipient of a substance or a preparation : means a downstream user or a distributor being supplied with a substance or a preparation;

Registrant means the manufacturer or the importer of a substance or the producer or importer of an product submitting a registration for a substance;

Registrant's own use means an industrial or professional use by the registrant;

Restriction means any condition for or prohibition of the manufacture, use or placing on the market;

Robust study summary means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report;

Scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 t per year;

Site means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;

SME means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises1;

Study summary means a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study;

Substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

Substances of Very High Concern CMR 1&2, PBTs, vPvBs:

  • Substances meeting the criteria for classification as carcinogenic category 1or 2
  • Substances meeting the criteria for classification as mutagenic category 1 or 2
  • Substances meeting the criteria for classification as toxic for reproduction category 1 or 2
  • Substances which are persistent, bioaccumulative and toxic
  • Substances which are very persistent and very bioaccumulative
  • Substances having endocrine disrupting properties
  • Current existing detailed lists from Directive 67/548/EEC and other EU legislations can be used as an interim /start base till EU commission has published candidates list and later develops final list.

Substances which occur in nature means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means;

Supplier of a product means any producer or importer of an product, distributor or other actor in the supply chain placing an product on the market;

Supplier of a substance or a preparation means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation;

Use and exposure category means an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use;

Use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an product or any other utilisation.