Definitions glossary - English
There are 32 entries in this glossary.All
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 |
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. |