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Definitions glossary - English

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Term Definition
Active substance

A substance or micro-organism that has an action on or against harmful organisms.

Administrative change

An amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family.

Advertising

A means of promoting the sale or use of biocidal products using printed, electronic or other media.

Applicant

A person or company dealing with the practical aspects of the authorisation procedure on behalf of the holder of the future authorisation (also called “third-party applicant”).

Authorisation holder

The person established within the Union who is responsible for the placing on the market of a biocidal product in a particular Member State or in the Union and specified in the authorisation.

Biocidal product
  • Any substance or mixture in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action
  • Any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action

A treated article that has a primary biocidal function shall be considered a biocidal product. A comprehensive list of twenty-two product types, including an indicative set of descriptions for each type, appears in Annex V to Regulation (EU) No 528/2012.

Existing active substance

Substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product- and process-oriented research and development.

Existing product

A product containing existing active substances that can benefit from the transitional measures defined in Article 89 of Regulation (EU) No 528/2012.

Harmful organism

An organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment.

Importer

Any natural person or legal entity that is established in the European Union and imports a substance or product into it.

Letter of Access

An original document, signed by the data owner or its representative, which states that these data may be used for the benefit of a third party by competent authorities, the Agency [ECHA] or the Commission for the purposes of Regulation (EU) No 528/2012.

Major change

Amendment of an existing authorisation which is neither an administrative change nor a minor change.

Micro-organism

Any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths.

Minor change

Amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited reassessment of the properties or efficacy of the biocidal product or biocidal product family.

Mutual recognition

A type of application seeking authorisation or registration in one Member State of a biocidal product that is already authorised or registered in another Member State, provided that the active substance of the biocidal product is approved as a biocidal active substance at European level.

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